6,170 Quality Systems jobs in the United States
Quality Systems Management- Quality Engineer 1
Posted today
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Job Description
Quality Systems Management- Quality Engineer 1
Location:
New Bremen, OH, US, 45869
Company Description:
Crown Equipment Corporation is a leading innovator in world-class forklift and material handling equipment and technology. As one of the world's largest lift truck manufacturers, we are committed to providing the customer with the safest, most efficient and ergonomic lift truck possible to lower their total cost of ownership.
Job Posting External
Responsibilities
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Support the multi-site organization in continuous improvement of quality and management systems.
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Prepare the organization for internal and external audits.
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Create, update, and main the Global Crown Quality Management Systems and procedures and ensure compliance with the ISO 9001 system.
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Coordinate the schedules, agendas, and accomodations for the ISO9001 external audits.
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Lead/ manage internal quality audits to ensure adherence to the QMS and to drive quality improvements.
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Train new auditors.
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Ensure findings are communicated across sites and functional groups.
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Participate in problem solving activities for non-conformances and validate corrective action implementation.
Qualification
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2-5 years of experience with the ISO 9001 Quality Management Systems.
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Bachelor's degree in a techinial field or equalent experience.
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ISO 9001:2015 Internal Audit Experience
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Knowledge of MD1/ MD and Quality Management Systems
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Ability to communicate effectively with various stakeholders, including techinical and non-techinical personnel.
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Ability to plan, organize, and manage quality improvement projects.
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Up to 10-20% travel with occasional overnight stay.
Preferred Qualification
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Certified ISO 900:2015 Lead Auditor
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Experience with Excel, Power BI and data management.
Work Authorization:
Crown will only employ those who are legally authorized to work in the United States. This is not a position for which sponsorship will be provided. Individuals with temporary visas or who need sponsorship for work authorization now or in the future, are not eligible for hire.
No agency calls please.
Compensation and Benefits:
Crown offers an excellent wage and benefits package for full-time employees including Health/Dental/Vision/Prescription Drug Plan, Flexible Benefits Plan, 401K Retirement Savings Plan, Life and Disability Benefits, Paid Parental Leave, Paid Holidays, Paid Vacation, Tuition Reimbursement, and much more.
EOE Veterans/Disabilities
Sr. Manager, Quality Systems Management
Posted 10 days ago
Job Viewed
Job Description
Mavericks WantedWhen was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement.read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.Affiliate OverviewEidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).What You'll DoThe Sr. Manager, Quality Systems Management will report to the Vice President of Quality, CMC tasked with a wide range of responsibilities that ensure the smooth functioning of quality processes within an organization. This position will be responsible for overseeing the development, implementation, and continuous improvement of the quality management systems (QMS) to ensure compliance with GxP regulatory standards and company policies. This position will also be responsible for overseeing the end-to-end compilation of Annual Product Quality Reviews (APQRs) and Quality Metrics for commercial marketed products. The role involves accurately and thoroughly collecting, analyzing, and summarizing product review data in a timely manner. The position will ensure compliance with the current regulated standards and internal procedures. This position will require strong cross-functional collaboration with internal stakeholders and external parties. ResponsibilitiesLead the creation, maintenance, and continuous improvement of the QMSOversee the preparation and compilation of APQR reports, leading and managing the APQR processDefine and generate quality metrics and Key Process Indicators (KPI) for Quality Management Reviews (QMRs), etc.Analyze and present quality data to identify trends, risks, and opportunities for improvement Lead process improvement initiatives and implement corrective and preventive actions (CAPAs)Collaborate with internal and external key stakeholders for the compilation of quality metrics, APQR, etc.Ensure timely compilation of APQR and approval of necessary reportsEscalate to management of potential trends, product quality, and regulatory compliance issuesParticipate in audits and regulatory inspectionsEnsure all activities comply with current GxP regulatory standards and internal proceduresEstablish work priorities to meet targets and timelines, and effectively manage competing priorities with minimal escalationsAssist in the preparation, review, and revision of Standard Operating Procedures (SOPs) as requiredOther duties as assignedWhere You'll WorkThis is a hybrid role and requires in-office collaboration as needed, in our San Francisco, CA office.Who You AreBachelor's degree or equivalent in pharmacy, science, mathematics, or engineering requiredA minimum of 10+ years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field, or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attainedKnowledge of Lean Six Sigma Methodologies or equivalent is preferredExcellent analytical, problem-solving, and project management skills with keen attention to detailKnowledge of regulatory requirements and guidelines (e.g., FDA, ICH, EU GMP, GDP)Proficiency in eQMS, preferably with prior Veeva experience, Microsoft Office, Excel, Google Docs, etc.Experience with commercial marketed productsRewarding Those Who Make the Mission PossibleWe have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits:Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2%Employee stock purchase programPre-tax commuter benefitsReferral program with $2,500 award for hired referralsHealth & Wellbeing:Comprehensive health care with 100% premiums covered - no cost to you and dependentsMental health support via Spring Health (6 therapy sessions & 6 coaching sessions)Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you needPaid parental leave - 4 months for birthing parents & 2 months for non-birthing parentsFlex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our officeSkill Development & Career Paths:People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobilityWe provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp CoachingWe celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunitiesAt BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.Salary$50,000- 190,000 USD
Manager, Quality Management Systems
Posted 2 days ago
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Manager, Quality Management Systems page is loaded Manager, Quality Management Systems Apply locations Phoenixville time type Full time posted on Posted 30+ Days Ago job requisition id JR100149 The Vacancy Job Title: Manager, Quality Management Systems & Metrology / LEAN Champion Department: Quality Overhead Reports To: Business General Manager Summary Statement: Under direction and partnership with the business General Manager, this Management team position has direct responsibility for leading the LEAN journey throughout the business along with discipline ownership of the Quality Management System and Measurement Sciences/Metrology. The LEAN journey focused on providing the overall business LEAN process education and continuous improvement guidance & leadership. The Quality System context defined as: planning and executing product manufacturing and post sales service for portable electronic test instruments and on-line monitoring systems, across the global electricity generation & transmission industry. Essential Job Responsibilities: • Serves as the ISO 9000 business management representative, leading all compliance audits. • Responsible for establishing, implementing, and directing all Quality Assurance efforts. • Establishes, Monitors, and provides Training for all Quality Management System procedures and processes. • Establishes, Leads, Monitors internal auditing program. • Ownership/Responsibility for Quality Management System and associated personnel: (defining needs, staffing, training, directing, coaching, evaluating, compensating, disciplining, enforcement of discipline procedures). • Ownership/Responsibility for Measurement Science & Equipment Metrology discipline and associated personnel: (defining needs, staffing, training, directing, coaching, evaluating, compensating, disciplining, procedure adherence). • Oversee/Ensure Quality of all in-house and out-house manufacturing operations, and process/procedure adherence… driving SCARs & CARs as required. • Establishes & Monitors Supplier Quality Assessment program. • Participate/Lead Supplier Management meetings (existing partner and new partner audits) driving overall performance requirements and objectives. • Provide Quality Systems perspective in support of business in-house/out-house sourcing decisions. • Participate in weekly Class 3/Class 4 status review and planning meetings, facilitating meeting all Quality goals. • Participate in weekly Change Control Review Meetings, gaining insight & knowledge to ensure Quality of phase in action plans (ECN review/approval). • Ensure business adherence to appropriate T&M instrument/equipment calibration, inspection, and testing methods. • Monitor, report and drive continuous improvements throughout the business as LEAN Champion. • Translate Megger Group Quality & LEAN objectives, actively manage Megger Excellence System charts. • Provide Leadership & Training to business on Megger Excellence System Quality & LEAN initiatives. • Participate in the annual business budgeting & review cycles (partnering with General Manager and Controller). o Capital Equipment Spend, Overhead %, Costs of Warranty, Costs of Poor Quality. • Monitor monthly Cost Center financial performance, taking corrective actions as needed. • Other duties as assigned. Communication skills: Advanced oral & written communication skills. Interpersonal skills: Professional, respectful, helpful, sincere, and energetic persona, business leader. Listening skills: Ability to hear & meet needs of business as communicated by business management, employees, and Megger Board leadership. Problem-solving skills: Advanced problem-solving skills: LEAN process tool kit usage across all disciplines of business: Manufacturing, Supply Chain Management, Material Management, Product Service, Customer Services, Product Development, Product Quality. Minimum Skill Sets and Competencies: • Undergraduate degree (Industrial or other Engineering, Business Administration, other). Graduate level degree viewed as differentiator. • 15 plus years of experience leading Quality and Lean initiatives with an electronic and/or electro-mechanical product manufacturer: High Mix, Low to Medium Volume manufacturing environment. • 10 plus years of experience: leading/supervising personnel within: Quality & Metrology. • 5 plus years of experience: using SAP ERP systems in electronic products manufacturing environment. • Demonstrated experience & advanced working knowledge: new product manufacturing introduction, documentation change control, supplier performance review management, and LEAN problem-solving processes. • Full working knowledge of ISO9001:2008/2015 certification attainment & maintenance. • Expert level skills leading business initiative teams comprised of direct and indirect personnel. • Expert level proficiency with Microsoft Office: Excel, Word, and PowerPoint. • Attention to detail mentality and appreciation of setting and meeting project deadlines. Additional Knowledge/Skills/Abilities: • Visible & vocal advocate of Quality in the workplace. • Visible & vocal advocate and facilitator of LEAN journey within the workplace (continuous improvement). • Demonstrated ability to multi-task with demonstrated ability to get things done. • Demonstrated organizational skills. External Contacts: Extensive • Manufacturing & Supplier Partners / Equipment & Tooling Suppliers / Component & Material Suppliers / LEAN Consultants / ISO Registrars • Global Megger Accounting & Manufacturing teams / Professional Societies Travel Requirements: • 0% to 10% #J-18808-Ljbffr
Quality Management Systems Coordinator
Posted 9 days ago
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Make your mark at the world's largest HVAC company
Daikin Applied is seeking a Quality Management Systems Coordinator to join our team. Come be a part of an exciting journey at Daikin Applied, where innovation and excellence drive our every endeavor!
Location: In office, Staunton, VA.
What you will do:
- Oversee the scheduling, training, and compliance to required internal and external audits
- Oversee the scheduling and compliance to required external / third-party audits
- Ensure audit alignment, schedule visibility, and collection of outputs in the system of record
- Develop common standards regarding documentation format, control, storage, and management
- Provide clear guidance on standardization of ISO-9001 practices, procedures, and formats to all required locations
- Examine potential system improvements such as software, registrars, and other elements of the Quality Management System
- Reviews the activities and responsibilities of departments outside of the Quality realm to determine if there needs to be inclusion into the Quality Management System
- Develop and/or enhance QMS strategies, processes, policies, communications, and guidelines to comply with quality standards and regulations (as defined by Daikin Applied leadership strategic direction and context of the organization)
- Engage with Leadership and Management teams communicating Quality objectives and KPIs, providing risk assessment data to support decisions
- This position includes up to 10% travel, domestic and international
What's in it for you:
- The ability to make an impact and shape your career with a company that is passionate about growth
- The support of an organization that believes it is vital to include and engage diverse people, perspectives, and ideas to achieve our best
Qualifications:
- 4-year bachelor's degree
- 5-7 years' experience in Quality Management Systems
- Knowledge of basic Quality tools
- Participated on certification audit (ISO 9001)
- Advanced knowledge and skills using Microsoft Office suite
- Lead auditor trained in ISO 9001 and proven track of relevant experience preferred
- Other relevant QMS standards a plus (TL9000, AS/EN 9100, ISO TS 22163) preferred
- Work visa sponsorship is not available for this position
Benefits:
- Daikin Applied offers the following benefits for this position, subject to applicable eligibility requirements:
- Multiple medical insurance plan options + dental and vision insurance
- 401K retirement plan with employer match
- Paid time off and company paid holidays
- Paid sick time in accordance with the federal, state, and local law
- Tuition Reimbursement after 6 months of continuous service
- The typical salary for this position ranges from $90,000-$148,800 in Virginia. The range displayed represents the pay range for all positions in the job grade which this position falls. Individual base pay will depend on a wide range of factors including your skills, qualifications, experience, and location.
Quality Management Systems Manager
Posted 22 days ago
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Job Description
Working Location: CALIFORNIA, SAN JOSE Workplace Flexibility: Onsite For more than 100 years,Olympus has focused on making peoples lives healthier, safer and more fulfilling. Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard ofpatient care so people everywhere can fulfill their desires, dreams, and lives. Our fiveCore Valuesempower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus . Job Description Manage staff responsible for the maintenance of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the maintenance and improvement of quality management systems at Olympus facilities in the U.S. manage and execute key Quality Projects. Job Duties Manage staff responsible for the maintenance of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the maintenance and improvement of quality management systems at Olympus facilities in the U.S. manage and execute key Quality Projects. Support current and future quality management system development. Work with management and technical personnel from various departments within Olympus to understand existing systems and processes for purposes of identifying and documenting the most efficient workflow sequence needed to support the development maintenance and improvement of quality management systems at Olympus facilities within the U.S. Oversee CAPA activities related to the San Josefacilities, including but not limited to, status monitoring reporting follow-up verification and closure activities. Support CAPA activities at other facilities within the U.S. as needed. Manage the backroom at routine and periodic audit and assessment activities at the San Jose facilities including internal and external audits and inspections required to ensure that QSR / ISO compliance is maintained at all levels of the organization. Support these activities at other Olympus locations as needed. Oversee special projects related to the development maintenance and improvement of Quality Management Systems and production or Quality Processes at Olympus facilities in the U.S. Perform all other essential duties as directed. Job Qualifications Required: 4-year Bachelor of Science degree Minimum of 5 years supervisory or management experience in a regulated medical industry (Medical Devices, Pharmaceuticals, Biologics). Minimum of 8 years' experience in Quality Assurance. Strong leadership skills / experience required. Quality System experience required. Experience effectively completing CAPAs and NCRs). Can teach Good Documentation practices. Strong knowledge of quality tools (Root Cause Analysis, Process Mapping). Periodic travel to other facilities to support quality initiatives or training. Preferred: Strongly prefer Lean or Six Sigma skills and experience (DMAIC). Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on: Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Caf, Fitness Center** Connected Culture you can embrace: Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance *US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefit and incentives . The anticipated base pay range for this full-time position working at this location is$124,873.00-$174,822.00/ year, plus potential for annual bonus (subject to plan eligibility and other requirements).Olympus considers a variety of factors when determining actual compensation for this positionincluding: level of experience, working location, and relevanteducation and certifications. At Olympus, we are committed to Our Purpose of making peoples lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . You Belong at Olympus We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1- ). Lets realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: | United States (US) | California (US-CA) | San Jose |Quality & Regulatory Affairs (QA/RA) #J-18808-Ljbffr
Quality Management Systems Manager

Posted today
Job Viewed
Job Description
**Workplace Flexibility:** **Onsite**
**_For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. ?_** **_?_**
?
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
?
Our five Core Values empower us to achieve Our Purpose:
**Patient Focus, Integrity, Innovation, Impact and Empathy.**
Learn more about Life at Olympus ( .
**Job Description**
Manage staff responsible for the maintenance of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the maintenance and improvement of quality management systems at Olympus facilities in the U.S. manage and execute key Quality Projects.
**Job Duties**
+ Manage staff responsible for the maintenance of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the maintenance and improvement of quality management systems at Olympus facilities in the U.S. manage and execute key Quality Projects.
+ Support current and future quality management system development.
+ Work with management and technical personnel from various departments within Olympus to understand existing systems and processes for purposes of identifying and documenting the most efficient workflow sequence needed to support the development maintenance and improvement of quality management systems at Olympus facilities within the U.S.
+ Oversee CAPA activities related to the San Jose facilities, including but not limited to, status monitoring reporting follow-up verification and closure activities.
+ Support CAPA activities at other facilities within the U.S. as needed.
+ Manage the backroom at routine and periodic audit and assessment activities at the San Jose facilities including internal and external audits and inspections required to ensure that QSR / ISO compliance is maintained at all levels of the organization.
+ Support these activities at other Olympus locations as needed.
+ Oversee special projects related to the development maintenance and improvement of Quality Management Systems and production or Quality Processes at Olympus facilities in the U.S.
+ Perform all other essential duties as directed.
**Job Qualifications**
**Required:**
+ 4-year Bachelor of Science degree
+ Minimum of 5 years supervisory or management experience in a regulated medical industry (Medical Devices, Pharmaceuticals, Biologics).
+ Minimum of 8 years' experience in Quality Assurance.
+ Strong leadership skills / experience required.
+ Quality System experience required.
+ Experience effectively completing CAPAs and NCRs).
+ Can teach Good Documentation practices.
+ Strong knowledge of quality tools (Root Cause Analysis, Process Mapping).
+ Periodic travel to other facilities to support quality initiatives or training.
**Preferred:**
+ Strongly prefer Lean or Six Sigma skills and experience (DMAIC).
**Why join Olympus?**
_We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture._
**Equitable Offerings you can count on:**
+ Competitive salaries, annual bonus and 401(k)* with company match
+ Comprehensive medical, dental, vision coverage effective on start date
+ 24/7 Employee Assistance Program
+ Free live and on-demand Wellbeing Programs
+ Generous Paid Vacation and Sick Time
+ Paid Parental Leave and Adoption Assistance*
+ 12 Paid Holidays
+ On-Site Child Daycare, Café, Fitness Center**
**Connected Culture you can embrace:**
+ Work-life integrated culture that supports an employee centric mindset
+ Offers onsite, hybrid and field work environments
+ Paid volunteering and charitable donation/match programs
+ Employee Resource Groups
+ Dedicated Training Resources and Learning & Development Programs
+ Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
**Are you ready to be a part of our team?**
Learn more about our benefit and incentives ( .
The anticipated base pay range for this full-time position working at this location is $124,873.00 - $174,822.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit .
**You Belong at Olympus**
We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.
**_Applicants Requesting Accommodations:_** Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1- ).
**Let's realize your potential, together.**
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: | United States (US) | California (US-CA) | San Jose | Quality & Regulatory Affairs (QA/RA)
Director, Quality Management Systems
Posted 19 days ago
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Job Description
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Your Role: Director, Quality Management Systems
Responsible for the design, implementation, continuous improvement, and oversight of robust Quality Management Systems (QMS) at the Elanco Fort Dodge site to support a risk-based quality culture in alignment with Elanco and industry standards. Monitors the health of the Elanco QMS at the Fort Dodge site and identifies cross-functional areas of opportunity or risk for action and reports to the appropriate quality governance.
Your Responsibilities:
- Leads Quality Management Systems (QMS): Implements, maintains, and improves QMS processes, ensuring compliance with regulations and Elanco standards. Provides technical guidance and training to the QMS team. Oversees budgets, authors the Site Quality Plan, and drives continuous improvement initiatives.
- Manage Audits and Inspections: Prepares for and manages regulatory inspections and corporate audits. Ensures inspection readiness, reviews QMS records, and drives timely completion of corrective actions.
- Provides Quality Governance: Develops and implements governance processes (e.g., Quality Lead Team, Deviation Review Board). Identifies and analyzes quality risks, reporting the overall state of QMS control to senior leadership.
- Oversees Training and Development: Develops and executes training programs for the Elanco QMS. Ensures training program effectiveness within the QMS department. Identifies professional development opportunities for self and team.
- Leads Investigations and CAPA: Reviews and approvals of manufacturing and Quality department investigations, ensuring compliance, root cause identification, and effective corrective and preventative actions (CAPA).
What You Need to Succeed (minimum qualifications):
- Education: Bachelor’s degree in science-related discipline.
- Experience: 10+ years’ experience in a regulated pharmaceutical/vaccine manufacturing environment. 5+ years of experience in people management including direct & indirect reports.
- Thorough knowledge of cGMP/GLP regulatory requirements for Biotech products, including direct experience with external audits (USDA, FDA, EMEA).
- Previous experience in department oversight (organizational, budgeting, strategy).
What will give you a competitive edge (preferred qualifications):
- Advanced degree highly preferred
- Demonstrated proficiency in lean/5S/six sigma methodologies
- Ability to set up partnerships with regulatory authorities to resolve quality & compliance issues.
- Versatility in conflict resolution, problem solving and working with cross functional teams.
- Sound business acumen and strategic mindset
Additional Information:
- Location: Fort Dodge, Iowa: On-Site Work Environment – Excellent relocation package available!
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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Quality Systems Specialist (Quality Systems Specialist-General)
Posted today
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Job Description
At Boeing, we innovate and collaborate to make the world a better place. We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportunity for professional growth. Find your future with us.
Boeing Commercial Airplanes (BCA) is hiring Experienced Quality Systems Specialists (Statistical Analysis & Application) (Level 3 or 4) support the 737 Customer Quality Support Team, supporting Renton and Seattle Delivery Center.
We are seeking a dedicated Quality Systems Specialist to join our team, focusing on enhancing customer quality support. The ideal candidate will be responsible for developing and maintaining dashboards that provide critical insights into product quality metrics. This role involves pulling and analyzing data to identify trends, raise awareness, and drive process improvements that ensure the highest quality of our products. The Quality Systems Specialist will collaborate closely with cross-functional teams to address customer concerns, enhance satisfaction, and ensure timely delivery of quality products. A strong analytical mindset and a commitment to continuous improvement are essential for success in this position.
Position Responsibilities:
- Dashboard Development: Design, implement, and maintain interactive dashboards to visualize quality metrics and performance indicators, enabling data-driven decision-making.
- Data Analysis: Collect, analyze, and interpret data related to product quality, customer feedback, and process performance to identify trends and areas for improvement.
- Process Improvement: Collaborate with cross-functional teams to develop and implement process improvement initiatives aimed at enhancing product quality and customer satisfaction.
- Customer Support: Act as a liaison between customers and internal teams to address quality-related inquiries, concerns, and feedback, ensuring timely resolution and communication.
- Reporting: Prepare and present regular reports on quality performance, trends, and improvement initiatives to stakeholders, highlighting key findings and recommendations.
- Quality Standards Compliance: Ensure adherence to industry quality standards and regulatory requirements, conducting audits and assessments as necessary.
- Training and Support: Provide training and support to team members on quality systems, tools, and best practices to foster a culture of quality within the organization.
- Continuous Improvement: Stay up-to-updated on industry best practices and emerging trends in quality management, applying this knowledge to enhance existing processes and systems.
- Executive Reporting: Develop comprehensive executive reports that summarize quality performance, key metrics, and improvement initiatives, providing insights for senior management.
- Presentation Development: Create engaging presentations for executive meetings, highlighting critical quality issues, trends, and recommendations for strategic decision-making.
- Stakeholder Communication: Effectively communicate quality-related findings and initiatives to stakeholders at all levels, ensuring clarity and alignment on quality objectives.
- Visual Data Representation: Utilize data visualization tools to present complex data in a clear and concise manner, making it accessible and understandable for executive audiences.
- Actionable Insights: Provide actionable insights and recommendations based on data analysis to support strategic planning and resource allocation related to quality initiatives.
- Feedback Integration: Gather feedback from executives and stakeholders on reports and presentations to continuously improve the quality and relevance of the information presented.
Basic Qualifications (Required Skills/Experience):
- 2+ years of experience working with quality and/or manufacturing data systems
- 2+ years of experience in database management, programming, statistical modeling and/or machine learning (SQL, R, Python, JMP, Tableau, etc.)
- 2+ years of experience with developing web applications
- Experience with C#, SQL, and HTML 5
Preferred Qualifications (Desired Skills/Experience):
- 2+ years of experience using Tableau
- 2+ years of experience in JavaScript
- Experience with systematic problem-solving skills.
- Experience working in a cross-functional environment and/or business unit team.
- Data Analysis, Data Mining, Database Design, UX Research, Product Deployment, Process Improvement, Project Management, Risk Management.
- Experience working within a fast-paced team environment which requires strong communication skills to frequently interact with Program Leadership, internal and external customer representatives and development teams.
Drug Free Workplace:
Boeing is a Drug Free Workplace where post offer applicants and employees are subject to testing for marijuana, cocaine, opioids, amphetamines, PCP, and alcohol when criteria is met as outlined in our policies.
Total Rewards and Pay Transparency:
At Boeing, we strive to deliver a Total Rewards package that will attract, engage and retain the top talent. Elements of the Total Rewards package include competitive base pay and variable compensation opportunities.
The Boeing Company also provides eligible employees with an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and a number of programs that provide for both paid and unpaid time away from work.
The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements.
Pay is based upon candidate experience and qualifications, as well as market and business considerations.
Summary pay ranges:
Level 3 - $91,800-$12,200/Annually
Level 4 - 113,400- 138,600/Annually
Applications for this position will be accepted until Jul. 26, 2025
Export Control Requirements: If the successful candidate is not a “U.S. Person“ (as defined by 22 C.F.R. § 120.15 “U.S. Person” includes U.S. citizens, lawful permanent residents, refugees, or asylees) and the position requires access to export-controlled data, an appropriate export authorization by the U.S. Government may be required prior to such access. Employment, and the continuity of employment of non-U.S. persons, is contingent upon the company’s ability to secure and maintain the necessary export control authorization.
Export Control Details: US based job, US Person not required
Relocation
Relocation assistance is not a negotiable benefit for this position.
Visa Sponsorship
Employer will not sponsor applicants for employment visa status.
Shift
This position is for 1st shift
Equal Opportunity Employer:
Boeing is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.
Quality Systems Specialist (Quality Systems Specialist-General)
Posted today
Job Viewed
Job Description
Job Description
At Boeing, we innovate and collaborate to make the world a better place. We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportunity for professional growth. Find your future with us.
Boeing Commercial Airplanes (BCA) is hiring Experienced Quality Systems Specialists (Statistical Analysis & Application) (Level 3 or 4) support the 737 Customer Quality Support Team, supporting Renton and Seattle Delivery Center.
We are seeking a dedicated Quality Systems Specialist to join our team, focusing on enhancing customer quality support. The ideal candidate will be responsible for developing and maintaining dashboards that provide critical insights into product quality metrics. This role involves pulling and analyzing data to identify trends, raise awareness, and drive process improvements that ensure the highest quality of our products. The Quality Systems Specialist will collaborate closely with cross-functional teams to address customer concerns, enhance satisfaction, and ensure timely delivery of quality products. A strong analytical mindset and a commitment to continuous improvement are essential for success in this position.
Position Responsibilities:
- Dashboard Development: Design, implement, and maintain interactive dashboards to visualize quality metrics and performance indicators, enabling data-driven decision-making.
- Data Analysis: Collect, analyze, and interpret data related to product quality, customer feedback, and process performance to identify trends and areas for improvement.
- Process Improvement: Collaborate with cross-functional teams to develop and implement process improvement initiatives aimed at enhancing product quality and customer satisfaction.
- Customer Support: Act as a liaison between customers and internal teams to address quality-related inquiries, concerns, and feedback, ensuring timely resolution and communication.
- Reporting: Prepare and present regular reports on quality performance, trends, and improvement initiatives to stakeholders, highlighting key findings and recommendations.
- Quality Standards Compliance: Ensure adherence to industry quality standards and regulatory requirements, conducting audits and assessments as necessary.
- Training and Support: Provide training and support to team members on quality systems, tools, and best practices to foster a culture of quality within the organization.
- Continuous Improvement: Stay up-to-updated on industry best practices and emerging trends in quality management, applying this knowledge to enhance existing processes and systems.
- Executive Reporting: Develop comprehensive executive reports that summarize quality performance, key metrics, and improvement initiatives, providing insights for senior management.
- Presentation Development: Create engaging presentations for executive meetings, highlighting critical quality issues, trends, and recommendations for strategic decision-making.
- Stakeholder Communication: Effectively communicate quality-related findings and initiatives to stakeholders at all levels, ensuring clarity and alignment on quality objectives.
- Visual Data Representation: Utilize data visualization tools to present complex data in a clear and concise manner, making it accessible and understandable for executive audiences.
- Actionable Insights: Provide actionable insights and recommendations based on data analysis to support strategic planning and resource allocation related to quality initiatives.
- Feedback Integration: Gather feedback from executives and stakeholders on reports and presentations to continuously improve the quality and relevance of the information presented.
Basic Qualifications (Required Skills/Experience):
- 2+ years of experience working with quality and/or manufacturing data systems
- 2+ years of experience in database management, programming, statistical modeling and/or machine learning (SQL, R, Python, JMP, Tableau, etc.)
- 2+ years of experience with developing web applications
- Experience with C#, SQL, and HTML 5
Preferred Qualifications (Desired Skills/Experience):
- 2+ years of experience using Tableau
- 2+ years of experience in JavaScript
- Experience with systematic problem-solving skills.
- Experience working in a cross-functional environment and/or business unit team.
- Data Analysis, Data Mining, Database Design, UX Research, Product Deployment, Process Improvement, Project Management, Risk Management.
- Experience working within a fast-paced team environment which requires strong communication skills to frequently interact with Program Leadership, internal and external customer representatives and development teams.
Drug Free Workplace:
Boeing is a Drug Free Workplace where post offer applicants and employees are subject to testing for marijuana, cocaine, opioids, amphetamines, PCP, and alcohol when criteria is met as outlined in our policies.
Total Rewards and Pay Transparency:
At Boeing, we strive to deliver a Total Rewards package that will attract, engage and retain the top talent. Elements of the Total Rewards package include competitive base pay and variable compensation opportunities.
The Boeing Company also provides eligible employees with an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and a number of programs that provide for both paid and unpaid time away from work.
The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements.
Pay is based upon candidate experience and qualifications, as well as market and business considerations.
Summary pay ranges:
Level 3 - $91,800-$12,200/Annually
Level 4 - 113,400- 138,600/Annually
Applications for this position will be accepted until Jul. 26, 2025
Export Control Requirements: If the successful candidate is not a “U.S. Person“ (as defined by 22 C.F.R. § 120.15 “U.S. Person” includes U.S. citizens, lawful permanent residents, refugees, or asylees) and the position requires access to export-controlled data, an appropriate export authorization by the U.S. Government may be required prior to such access. Employment, and the continuity of employment of non-U.S. persons, is contingent upon the company’s ability to secure and maintain the necessary export control authorization.
Export Control Details: US based job, US Person not required
Relocation
Relocation assistance is not a negotiable benefit for this position.
Visa Sponsorship
Employer will not sponsor applicants for employment visa status.
Shift
This position is for 1st shift
Equal Opportunity Employer:
Boeing is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.
Quality Systems Specialist (Quality Systems Specialist-General)
Posted 3 days ago
Job Viewed
Job Description
At Boeing, we innovate and collaborate to make the world a better place. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, with great opportunity for professional growth. Find your future with us.
**Boeing Commercial Airplanes (BCA)** is hiring **Experienced Quality Systems Specialists (Statistical Analysis & Application)** (Level 3 or 4) support the **737 Customer Quality Support Team,** supporting Renton and Seattle Delivery Center.
We are seeking a dedicated Quality Systems Specialist to join our team, focusing on enhancing customer quality support. The ideal candidate will be responsible for developing and maintaining dashboards that provide critical insights into product quality metrics. This role involves pulling and analyzing data to identify trends, raise awareness, and drive process improvements that ensure the highest quality of our products. The Quality Systems Specialist will collaborate closely with cross-functional teams to address customer concerns, enhance satisfaction, and ensure timely delivery of quality products. A strong analytical mindset and a commitment to continuous improvement are essential for success in this position.
**Position Responsibilities:**
+ Dashboard Development: Design, implement, and maintain interactive dashboards to visualize quality metrics and performance indicators, enabling data-driven decision-making.
+ Data Analysis: Collect, analyze, and interpret data related to product quality, customer feedback, and process performance to identify trends and areas for improvement.
+ Process Improvement: Collaborate with cross-functional teams to develop and implement process improvement initiatives aimed at enhancing product quality and customer satisfaction.
+ Customer Support: Act as a liaison between customers and internal teams to address quality-related inquiries, concerns, and feedback, ensuring timely resolution and communication.
+ Reporting: Prepare and present regular reports on quality performance, trends, and improvement initiatives to stakeholders, highlighting key findings and recommendations.
+ Quality Standards Compliance: Ensure adherence to industry quality standards and regulatory requirements, conducting audits and assessments as necessary.
+ Training and Support: Provide training and support to team members on quality systems, tools, and best practices to foster a culture of quality within the organization.
+ Continuous Improvement: Stay up-to-updated on industry best practices and emerging trends in quality management, applying this knowledge to enhance existing processes and systems.
+ Executive Reporting: Develop comprehensive executive reports that summarize quality performance, key metrics, and improvement initiatives, providing insights for senior management.
+ Presentation Development: Create engaging presentations for executive meetings, highlighting critical quality issues, trends, and recommendations for strategic decision-making.
+ Stakeholder Communication: Effectively communicate quality-related findings and initiatives to stakeholders at all levels, ensuring clarity and alignment on quality objectives.
+ Visual Data Representation: Utilize data visualization tools to present complex data in a clear and concise manner, making it accessible and understandable for executive audiences.
+ Actionable Insights: Provide actionable insights and recommendations based on data analysis to support strategic planning and resource allocation related to quality initiatives.
+ Feedback Integration: Gather feedback from executives and stakeholders on reports and presentations to continuously improve the quality and relevance of the information presented.
**Basic Qualifications (Required Skills/Experience):**
+ 2+ years of experience working with quality and/or manufacturing data systems
+ 2+ years of experience in database management, programming, statistical modeling and/or machine learning (SQL, R, Python, JMP, Tableau, etc.)
+ 2+ years of experience with developing web applications
+ Experience with C#, SQL, and HTML 5
**Preferred Qualifications (Desired Skills/Experience):**
+ 2+ years of experience using Tableau
+ 2+ years of experience in JavaScript
+ Experience with systematic problem-solving skills.
+ Experience working in a cross-functional environment and/or business unit team.
+ Data Analysis, Data Mining, Database Design, UX Research, Product Deployment, Process Improvement, Project Management, Risk Management.
+ Experience working within a fast-paced team environment which requires strong communication skills to frequently interact with Program Leadership, internal and external customer representatives and development teams.
**Drug Free Workplace:**
Boeing is a Drug Free Workplace where post offer applicants and employees are subject to testing for marijuana, cocaine, opioids, amphetamines, PCP, and alcohol when criteria is met as outlined in our policies _._
**Total Rewards and Pay Transparency:**
At Boeing, we strive to deliver a Total Rewards package that will attract, engage and retain the top talent. Elements of the Total Rewards package include competitive base pay and variable compensation opportunities.
The Boeing Company also provides eligible employees with an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and a number of programs that provide for both paid and unpaid time away from work.
The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements.
Pay is based upon candidate experience and qualifications, as well as market and business considerations.
**Summary pay ranges:**
**Level 3 - $91,800-$12,200/Annually**
**Level 4 - 113,400- 138,600/Annually**
Applications for this position will be accepted until **Jul. 26, 2025**
**Export Control Requirements:** If the successful candidate is not a "U.S. Person" (as defined by 22 C.F.R. § 120.15 "U.S. Person" includes U.S. citizens, lawful permanent residents, refugees, or asylees) and the position requires access to export-controlled data, an appropriate export authorization by the U.S. Government may be required prior to such access. Employment, and the continuity of employment of non-U.S. persons, is contingent upon the company's ability to secure and maintain the necessary export control authorization.
**Export Control Details:** US based job, US Person not required
**Relocation**
Relocation assistance is not a negotiable benefit for this position.
**Visa Sponsorship**
Employer will not sponsor applicants for employment visa status.
**Shift**
This position is for 1st shift
**Equal Opportunity Employer:**
Boeing is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.
Boeing is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.