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26 Quality Control jobs in Cleveland

Quality Control Associate I, Bioanalytical Chemistry

44101 Cleveland, Ohio Charles River Laboratories

Posted 4 days ago

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Job Description

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
**Job Summary**
We are seeking a QC Associate I for our Bioanalytical Chemistry Team at our Safety Assessment site located in Cleveland, OH.
Perform QC review of study data and perform inspections. Monitor and track common errors and assist with document modification to reduce error and deviations. Assist with implementing and monitoring quality control (QC) standards, methods, and procedures.
Essential Duties and Responsibilities: _(The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:_
+ Efficiently review all procedures, materials, and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.).
+ Demonstrate effective communication skills through informal discussions with peers, supervisor, and team.
+ Assist with maintenance/review of equipment.
+ Actively participate in process improvement initiatives with oversight.
+ Assist with training, as applicable.
+ Perform general QC practices as well as perform QC reviews of daily study data in one QC discipline.
+ Perform lab walk inspections.
+ Participate in Liaison Meetings.
+ Assist in recommending form and SOP modifications, and changes to standard protocol wording to avoid deviations.
+ Actively participate in logbook review and other projects as assigned.
+ Assist in maintaining and revising QC documents, processes, and manuals.
+ Actively participate in 1:1 meetings.
+ Performs all other related duties and functions as assigned.
The pay for this position is $21/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
**Job Qualifications**
_(Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:_
+ Education: High School diploma or General Education Degree (G.E.D.) or equivalent with 1 year of relevant experience preferred. Associate's degree (A.A./A.S.) or equivalent from a two-college recommended. Bachelor's degree (B.A./B.S.) in a relevant field with no work experience strongly recommended.
+ Experience: Previous QC or QA experience preferred. Knowledge and/or background in preclinical technical functions also preferred.
+ An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
+ Certification/Licensure: None.
+ Other: Demonstrated leadership and word processing skills. Effective written, verbal and communication skills.
Physical Demands
+ Must be able to lift, move, manipulate and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or supplies.
+ Must be able to perform procedures, standing or sitting, for long periods of time, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
+ Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.
+ Must be able to regularly provide information to and receive information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange information in these situations.
+ Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
+ Move about inside the work area to access file cabinets, office machinery, etc.
+ Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
Work Environment
+ General office and lab working conditions, the noise level in the work environment is usually quiet.
+ While performing the duties of this job the employee is regularly required to wear protective clothing (i.e., goggles, face shield, cap, gloves, scrubs, shoe covers), work near toxic or caustic chemicals, work with biohazards.
+ The employee may occasionally be exposed to live animals with risk of exposure to allergens, zoonotic disease, and biohazards.
+ The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and extreme temperature conditions.
+ The noise level in the work environment ranges from low to moderate depending upon the task being performed.
Comments
+ This position may require overtime, weekend, holiday, and/or after hours shift coverage, as needed.
**About Safety Assessment**
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
**About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
**Equal Employment Opportunity**
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit

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Operations Consulting - Manufacturing Excellence (Quality Control) - Associate

44101 Cleveland, Ohio PwC

Posted 1 day ago

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Job Description

**Specialty/Competency:** Operations
**Industry/Sector:** Not Applicable
**Time Type:** Full time
**Travel Requirements:** Up to 80%
At PwC, our people in operations consulting specialise in providing consulting services on optimising operational efficiency and effectiveness. These individuals analyse client needs, develop operational strategies, and offer guidance and support to help clients streamline processes, improve productivity, and drive business performance.
In product development and manufacturing at PwC, you will specialise in improving product development and manufacturing processes. You will work closely with clients to analyse product development lifecycles, identify bottlenecks, and develop strategies to enhance speed to market, reduce costs, and improve quality. Working in this area, you will also provide guidance on implementing lean manufacturing principles, optimising supply chain integration, and leveraging digital technologies.
Driven by curiosity, you are a reliable, contributing member of a team. In our fast-paced environment, you are expected to adapt to working with a variety of clients and team members, each presenting varying challenges and scope. Every experience is an opportunity to learn and grow. You are expected to take ownership and consistently deliver quality work that drives value for our clients and success as a team. As you navigate through the Firm, you build a brand for yourself, opening doors to more opportunities.
Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to:
+ Apply a learning mindset and take ownership for your own development.
+ Appreciate diverse perspectives, needs, and feelings of others.
+ Adopt habits to sustain high performance and develop your potential.
+ Actively listen, ask questions to check understanding, and clearly express ideas.
+ Seek, reflect, act on, and give feedback.
+ Gather information from a range of sources to analyse facts and discern patterns.
+ Commit to understanding how the business works and building commercial awareness.
+ Learn and apply professional and technical standards (e.g. refer to specific PwC tax and audit guidance), uphold the Firm's code of conduct and independence requirements.
**Bachelors Degree Required**
**Preferred Fields of Study**
Biomedical Science,Aerospace Engineering,Automotive Engineering,Biomedical Engineering,Chemical Engineering,Computer Engineering,Engineering,Engineering Mechanics,Engineering Physics,Industrial and Operations Engineering,Industrial Engineering,Materials Science and Engineering,Production Engineering,Project Engineering & Management,Mechanical Engineering,Computer and Information Science,Data Processing/Analytics/Science
**Preferred Knowledge/Skills**
Demonstrates knowledge and a proven record of success in or a desire to deliver advisory services in one of the following core industry sectors including, but not limited to:
- Life Sciences: Pharma, Bio Pharma, & Specialty Pharma;ÊMedical Device, Medical Technology & Diagnostics; Generics; or, Animal Health; and,
- Industrial: Automotive; Aerospace; Chemicals; Industrial Manufacturing; or, Construction;
- Technology: Hardware/Electronics; Systems; Software; Semiconductor; or, Telecommunications;
**Functional Experience:**
Demonstrates knowledge and a proven record of success in or a desire to deliver advisory services in the following capability areas:
Experience in the pharmaceutical or medical device industry and/or top consulting firms with a focus on Pharma/Life Sciences.
Experience with Quality IT systems (eQMS, Veeva, Trackwise, etc.).
Knowledgeable in business processes in quality roles, manufacturing, or lab operations.
Key experience: (e.g., process engineering, process validation) and strong management consulting intrinsics such as communication, adaptability, and learning agility.
- Operations Excellence;
- Basic problem solving and analysis skills;
- Financial modeling skills;
- Basic spreadsheet, presentation and document development skills;
- Demonstrates the ability to build, maintain, and utilize networks of client relationships;
- Interpersonal skills and proactive communication; and,
- Collaborative and "can-do" mindset eager to take on challenges.
Learn more about how we work: does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. 
For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all.
Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: salary range for this position is: $63,000 - $140,000, plus individuals may be eligible for an annual discretionary bonus. For roles that are based in Maryland, this is the listed salary range for this position. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link:

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Operations Consulting - Manufacturing Excellence (Quality Control) - Manager

44101 Cleveland, Ohio PwC

Posted 4 days ago

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Job Description

**Specialty/Competency:** Operations
**Industry/Sector:** Not Applicable
**Time Type:** Full time
**Travel Requirements:** Up to 80%
At PwC, our people in operations consulting specialise in providing consulting services on optimising operational efficiency and effectiveness. These individuals analyse client needs, develop operational strategies, and offer guidance and support to help clients streamline processes, improve productivity, and drive business performance.
In product development and manufacturing at PwC, you will specialise in improving product development and manufacturing processes. You will work closely with clients to analyse product development lifecycles, identify bottlenecks, and develop strategies to enhance speed to market, reduce costs, and improve quality. Working in this area, you will also provide guidance on implementing lean manufacturing principles, optimising supply chain integration, and leveraging digital technologies.
**Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and values in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same.**
**Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to:**
**Analyse and identify the linkages and interactions between the component parts of an entire system.**
**Take ownership of projects, ensuring their successful planning, budgeting, execution, and completion.**
**Partner with team leadership to ensure collective ownership of quality, timelines, and deliverables.**
**Develop skills outside your comfort zone, and encourage others to do the same.**
**Effectively mentor others.**
**Use the review of work as an opportunity to deepen the expertise of team members.**
**Address conflicts or issues, engaging in difficult conversations with clients, team members and other stakeholders, escalating where appropriate.**
**Uphold and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements.**
**Job Requirements and Preferences**
**_Basic Qualifications_**
Minimum Degree Required: Bachelor's Degree
Minimum Year(s) of Experience: 5 year(s)
**_Preferred Qualifications:_**
Master's Degree
**Functional Experience:**
**Demonstrates knowledge and a proven record of success in or a desire to deliver advisory services in the following capability areas:**
**Experience in the pharmaceutical or medical device industry and/or top consulting firms with a focus on Pharma/Life Sciences.**
**Experience with Quality IT systems (eQMS, Veeva, Trackwise, etc.).**
**Knowledgeable in business processes in quality roles, manufacturing, or lab operations.**
**Key experience: (e.g., process engineering, process validation) and strong management consulting intrinsics such as communication, adaptability, and learning agility.**
**- Operations Excellence;**
**- Maintenance & Reliability Management;**
**- Digital Manufacturing; and,**
**- Digital Automation.Demonstrates some proven abilities to collaborate and work with a diverse team including:**
**- Basic problem solving and analysis skills;**
**- Financial modeling skills;**
**- Basic spreadsheet, presentation and document development skills;**
**- Demonstrates the ability to build, maintain, and utilize networks of client relationships;**
**- Interpersonal skills and proactive communication; and,**
**- Collaborative and "can-do" mindset eager to take on challenges**
Learn more about how we work: does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. 
For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all.
Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: salary range for this position is: $99,000 - $232,000, plus individuals may be eligible for an annual discretionary bonus. For roles that are based in Maryland, this is the listed salary range for this position. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link:

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Operations Consulting - Manufacturing Excellence (Quality Control) - Senior Manager

44101 Cleveland, Ohio PwC

Posted 4 days ago

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Job Description

**Specialty/Competency:** Operations
**Industry/Sector:** Not Applicable
**Time Type:** Full time
**Travel Requirements:** Up to 80%
A career in Physical Product Development and Manufacturing, within Operations Consulting, will provide you with the opportunity to help organizations uncover enterprise insights and drive business results using smarter data analytics. We focus on a collection of organizational technology capabilities, including business intelligence, data management, and data assurance that help our clients drive innovation, growth, and change within their organizations in order to keep up with the changing nature of customers and technology. You'll make impactful decisions by mixing mind and machine to leverage data, understand and navigate risk, and help our clients gain a competitive edge. Our Product Development and Manufacturing team expertly combines Strategy, Operational, and Digital consulting capabilities to help our clients innovate, develop and manufacture products in a manner that helps establish differentiated products, significantly increases operational efficiency and drives new levels of enterprise-wide growth in a connected world. We pair our functional expertise with PwC's deep industry sector experience to create unmatched value opportunities with our clients in the Industrial Products, Consumer Markets, Pharma Life Science, and Technology Media Telecom industry sectors. We foster and encourage a teaming culture that rewards collaboration, diversity, and inclusiveness while working diligently to drive value for our clients.
To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be a purpose-led and values-driven leader at every level. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future.
As a Senior Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to:
Encourage everyone to have a voice and invite opinion from all, including quieter members of the team.
Deal effectively with ambiguous and unstructured problems and situations.
Initiate open and candid coaching conversations at all levels.
Move easily between big picture thinking and managing relevant detail.
Anticipate stakeholder needs, and develop and discuss potential solutions, even before the stakeholder realises they are required.
Contribute technical knowledge in area of specialism.
Contribute to an environment where people and technology thrive together to accomplish more than they could apart.
Navigate the complexities of cross-border and/or diverse teams and engagements.
Initiate and lead open conversations with teams, clients and stakeholders to build trust.
Uphold the firm's code of ethics and business conduct.
**Preferred Knowledge/Skills**
Demonstrates knowledge and a proven record of success in or a desire to deliver advisory services in one of the following core industry sectors including, but not limited to:
- Life Sciences: Pharma, Bio Pharma, & Specialty Pharma;ÊMedical Device, Medical Technology & Diagnostics; Generics; or, Animal Health; and,
- Consumer Markets: Food & Beverage; Goods; or, Vertically Integrated Retail.
**Functional Experience:**
Demonstrates knowledge and a proven record of success in or a desire to deliver advisory services in the following capability areas:
Experience in the pharmaceutical or medical device industry and/or top consulting firms with a focus on Pharma/Life Sciences.
Experience with Quality IT systems (eQMS, Veeva, Trackwise, etc.).
Knowledgeable in business processes in quality roles, manufacturing, or lab operations.
Key experience: (e.g., process engineering, process validation) and strong management consulting intrinsics such as communication, adaptability, and learning agility.
- **Operations Excellence;**
- Demonstrates some proven abilities to collaborate and work with a diverse team including:
- Basic problem solving and analysis skills;
- Financial modeling skills;
- Basic spreadsheet, presentation and document development skills;
- Demonstrates the ability to build, maintain, and utilize networks of client relationships;
- Interpersonal skills and proactive communication; and,
- Collaborative and "can-do" mindset eager to take on challenges.
**Basic Qualifications**
Minimum Degree Required (BQ)
Bachelor's Degree
Minimum Year(s) of Experience (BQ)
7 year(s)
Preferred Qualifications
Degree Preferred
Master's Degree
Learn more about how we work: does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. 
For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all.
Applications will be accepted until the position is filled or the posting is removed, unless otherwise set forth on the following webpage. Please visit this link for information about anticipated application deadlines: salary range for this position is: $124,000 - $280,000, plus individuals may be eligible for an annual discretionary bonus. For roles that are based in Maryland, this is the listed salary range for this position. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link:

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Quality Assurance Manager

44101 Cleveland, Ohio GE HealthCare

Posted 22 days ago

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Job Description

**Job Description Summary**
Job Description Summary
This position is in GE Healthcare's MIM Software business which makes vendor-neutral imaging software to standardize your workflow and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM® to give patients more precise, personalized care.
QA Manager is a versatile and dynamic member of the Quality team. The QA Manager will support the CAPA system, Complaint Management and Document Control activities to ensure that processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software. They will also keep up to date with the requirements of the industry and develop a deep understanding of company processes to build a robust and efficient QMS to support the business. The QA Manager is responsible for adherence to the MIM Software Quality System.
As a critical member of the team, you will ensure adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. By employing strong critical thinking and influencing skills, you will work cross-functionally to ensure robust quality decisions. In this role, you will have a direct impact on ensuring patient safety, audit readiness, and the commercial delivery of MIM Software/ GE HealthCare systems.
**Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.**
**Job Description**
**What You'll Do:**
+ Ensure QMS processes such as Document Control, Complaint Management, Post-Market activities, CAPA, Training, etc meet all applicable quality & regulatory standards.
+ Write, update, and review quality documents, procedures, policies and business processes ensuring on-going compliance with current regulations, standards and applicable certifications.
+ Assist and lead in investigating nonconformities and use appropriate tools to determine the root cause.
+ Develop product knowledge to make informed decisions that influence product quality and safety.
+ Support audits by promptly delivering complete and accurate records.
+ Work with other stakeholders in the company to track and monitor successes and pain points of QMS processes.
+ Implement improvements to drive compliance, quality, and efficiency of these processes.
+ Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed.
+ Assist during audits in the room (supplier, critical supplier, notified body, or otherwise)
+ Proficient knowledge of MIM's product portfolios and Primary Products and classifications.
+ Stay current with the latest guidance documents, regulatory requirements, and industry best practices.
+ Assist in other areas of the QMS as directed by the manager.
**What You'll Need:**
+ Bachelor's degree from an accredited university or college.
+ At least 7 years of relevant experience in Quality Assurance in a regulated industry, either Medical Devices or Pharmaceuticals, preferably with Software as a Medical Device (SaMD)
+ Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including but not limited to FDA CFR 21 820, ISO 13485, and MDSAP.
+ Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available.
+ Demonstrated experience in leading and managing a team effectively.
+ Demonstrated ability to collaborate effectively and resolve conflicts.
**Desired Characteristics:**
+ Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design Engineering or Manufacturing Engineering in the Medical Device field.
+ Demonstrated expertise in root cause analysis.
+ Strong influencing skills and ability to clearly communicate the requirements to cross-functional teams.
+ Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills.
+ Proficiency in managing multiple priorities effectively.
+ Thrives in a dynamic environment and is comfortable navigating change
+ Takes initiative, manages time effectively, and is motivated to achieve goals without constant oversight. You're proactive in identifying opportunities and solving problems independently.
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
**Additional Information**
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer ( . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
**Relocation Assistance Provided:** No

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Quality Assurance Supervisor (Bid)

44101 Cleveland, Ohio Maximus

Posted 9 days ago

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Job Description

Permanent

Description & Requirements

We are currently seeking qualified and motivated professionals interested in joining our team in support of an upcoming federal contract (pending award). This position will play a key role in delivering high-quality services to our government client and will be contingent upon contract award.

As part of this project, you will support a federally funded initiative that provides essential medical readiness services-such as exams, screenings, dental care and preventive care-to individuals in remote or underserved areas. Services are delivered through a network of providers and mobile teams, with remote coordination and scheduling. The program ensures consistent access to care across dispersed populations and contributes to broader public service goals.

The Quality Assurance Supervisor is responsible for supporting and overseeing a team of QA Analysts to ensure adherence to production standards and that all project service level requirements and goals are met. The QA Supervisor acts as a primary source of reference and assists with escalated issues or cases as needed in a fast-paced, high-volume environment. This is a remote position.

Per contact requirements, this position is open only to U.S. citizens.

***Please note that this position is contingent upon bid award***

Essential Duties and Responsibilities:

- Assist management with department/project objectives.

- Provide ongoing supervision to assigned staff.

- Responsible for reporting issues, problems, and concerns to management.

- Complete daily, weekly, and monthly reports.

- Participate in the training of new staff.

- Assist the Manager in preparing presentation schedules and staff development plans.

- Monitor workload and coordinates schedules.

- Responsible for coaching team, setting expectations, conducting performance appraisals, and providing career development, corrective action and recognition for assigned staff.

- Monitor and evaluate performance.

- Educate specialists on department objective and performance metrics.

- Conduct quality reviews of the work of specialists to ensure accuracy and provides coaching when required and recognizes specialists with superior performance.

- Evaluate the need for training to ensure specialists maintain current knowledge of multiple programs.

- Provide the Manager with updates on all issues regarding quality, training, policy, procedures, staff issues and departmental performance levels.

- Ensure compliance with company Wage & Hour policy, including ensuring non-exempt employees get the rest & meal breaks.
- Comply with all company required policies, procedures and processes including but not limited to required training.

- Responsible for adhering to established safety standards.
- Perform other duties as assigned by management.

Minimum Requirements

- Bachelor's degree in relevant field of study and 3+ years of relevant professional experience required, or equivalent combination of education and experience.

- At least three (3) years of quality assurance in healthcare, medical documentation, government contracting, or a similar environment.

- Minimum of one (1) year of people management experience, preferably overseeing QA or QC staff.

- Excellent attention to detail and analytical skills.

- Excellent organizational, interpersonal, written, ability to and verbal communication skills.

- Prior experience in a call center environment preferred.

- Per contact requirements, this position is open only to U.S. citizens.

EEO Statement

Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics.

Pay Transparency

Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances.

Accommodations
Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at .

Minimum Salary

$

50,000.00

Maximum Salary

$

89,000.00

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Acting Quality Assurance Coordinator

44101 Cleveland, Ohio Maximus

Posted 11 days ago

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Job Description

Permanent

Description & Requirements

Maximus is currently seeking Acting Quality Assurance Coordinator's to support our Maryland Health Insurance Exchange (MD HIX) project. This is a remote opportunity. As the Acting Quality Assurance Coordinator, you'll be responsible for monitoring, evaluating and directing staff members on the quality of work performed as measured against project standards, contractual requirements and performance measures.

Essential Duties and Responsibilities:

- Responsible for evaluating staff members on the quality of work performed as measured against project standards, contractual requirements, and performance measures.

- Assist with the development, design, and recommend strategies or activities intended to improve performance.

- Assist with the development, analysis and distribution of project reports and performance indicators.

- Regularly assess the knowledge needs of the staff related to processes and policies regarding the client/contract operations and develop plans to meet those requirements.

- Conduct monitoring activities for quality assurance purposes.

- Assist with monitoring performance and meeting contractual requirements.

- Remain up-to-date on policies and procedures for all operations, assists in developing new procedures, and updates existing procedures when changes occur.

- Assist in the production and update of staff resource materials including quick reference guide, matrices, charts, and workflows.

- Assist with staff training, as necessary.

- Perform other duties as may be assigned by corporate management.

Minimum Requirements

- High school diploma or GED required and 0-2 years of relevant professional experience required, or equivalent combination of education and experience.

- Experience on the MD HIX project required.
- Must be willing and able to accept an acting position.

- Quality Assurance experience preferred.

Home Office Requirements:

- Internet speed of 20mbps or higher required (you can test this by going to

- Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router.

- Must currently and permanently reside in the Continental US.

Minimum Salary

$

19.00

Maximum Salary

$

21.00

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Senior Project Manager, Quality Assurance

44101 Cleveland, Ohio Molina Healthcare

Posted 3 days ago

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Job Description

**Job Description**
**Job Summary**
Interfaces with internal and external customers in reviewing scope and developing requirements and plans for testing / quality assurance for enterprise projects of considerable complexity. Works with cross functional teams to prepare comprehensive test design specifications for functional, regression, performance and security testing. Performs analysis to identify dependency points and common areas across multiple projects and optimizes the testing effort to reduce duplication. Manages project test resources in the development of large multi-system, multi-platform projects. Responsible for accurate and timely creation of test artifacts, tasks, execution schedule / plan, and manages stakeholder signoff. Closely reviews and tracks test execution and identifies risk, provides mitigation plan and communicates with project stakeholders and leadership. Manages test metrics such as sprint test velocity, defect density and defect leakage and identifies QA improvement opportunities. Understands and implements industry leading testing trends, tools and technologies such as AI, automation, etc.
**Job Duties**
- Works closely with customers to develop test requirements for major cross functional enterprise projects
- Prepares test design specifications for functional, regression, performance and security testing
- Creates, reviews, analyzes and estimates project test requests and scope.
- Performs research and analysis of customer-initiated inquiries and requests, utilizing technical tools as necessary to fully test reported issues/requirements .
- Fields direct questions from project and cross functional teams regarding business, technical and operations rules that may impact testing.
- Develops technical tests to validate complex business and system problems.
- Provides guidance for development teams through project testing as needed.
- Provides excellent customer service to internal and external customers handling all aspects of client relations concerning testing for technical projects, including notifying the client of implementation schedules and co-ordination and assistance in presentation of results.
- Provides leadership by mentoring others and sharing business and system knowledge.
- Develops, reviews and validates test results per requirements.
- Develops and documents test plans and works with stakeholders to review and obtain signoff prior to starting test execution. Monitors for material changes to the test scope and manages the changes through formal change request process
- Creates, presents and executes functional and acceptance test cases in accordance with the requirements of the solution/project.
- Manages complex project testing tasks from requirements review through deployment, including work assignment, prioritization, issue triage etc.
- Understands other Molina changes in process that may impact the customer and notifies the customer of such changes well ahead of their implementation.
- Able to work in a cross functional project team setting while also able to complete tasks individually within the provided timeline or as needed, accelerated timeline to meet the desired deployment deadline.
- Provides oversight across testing teams of multiple projects to identify risk and provide mitigation and ensure timely delivery
**Job Qualifications**
**REQUIRED EDUCATION:**
-Bachelor's Degree in Business Administration or Information Technology or equivalent combination of education and experience
**REQUIRED EXPERIENCE/KNOWLEDGE, SKILLS & ABILITIES:**
7 + years experience in a combination of applicable business and business systems
**PHYSICAL DEMANDS:**
Working environment is generally favorable and lighting and temperature are adequate. Work is generally performed in an office environment in which there is only minimal exposure to unpleasant and/or hazardous working conditions. Must have the ability to sit for long periods. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function.
To all current Molina employees: If you are interested in applying for this position, please apply through the intranet job listing.
Molina Healthcare offers a competitive benefits and compensation package. Molina Healthcare is an Equal Opportunity Employer (EOE) M/F/D/V.
Pay Range: $77,969 - $171,058 / ANNUAL
*Actual compensation may vary from posting based on geographic location, work experience, education and/or skill level.

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Regulatory Reporting Quality Assurance Analyst

44101 Cleveland, Ohio Huntington National Bank

Posted 4 days ago

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Job Description

Description
Summary:
The Finance Data Governance Analyst will partner closely with key stakeholders including Internal Audit, Line of Business teams, Data Stewards, and Technology SMEs to drive data quality improvements within the Finance data ecosystem. Analyzes business data and other data relationships to evaluate and report on the level of data quality. Lead performer on data quality activities that support key compliance and regulatory processes. Perform data discovery, profiling and root cause analysis on data assets. Assist in developing recommendations and implement improvements to data quality controls and monitoring processes. Provide support to Finance data management team responsible for building out next generation data quality capabilities.
Duties and Responsibilities:
+ Collaborate with stakeholders to develop and implement data quality improvements in Finance data ecosystem
+ Analyzes business data and other data relationships to evaluate and report on the level of data quality
+ Lead performer on data quality activities that support key compliance and regulatory processes
+ Perform data discovery, profiling and root cause analysis on data assets
+ Assist in developing recommendations and implement improvements to data quality and processes
+ Other duties as assigned
Basic Qualifications:
+ 3+ years experience in finance and financial data/data quality support
+ Bachelor's Degree or equivalent in scope of experience

Preferred Qualifications:
+ Bachelor's in Finance or Information Technology or equivalent
+ Experience with particular technologies: OFSAA, AXIOM, BI tools, Database analytic tools, knowledge of finance business processes and the interaction between systems and processes, including strong Excel skills, database query skills, the Record to Report (R2R) cycle, and the management reporting cycle.
Exempt Status: (Yes = not eligible for overtime pay) (No = eligible for overtime pay)
Yes
Workplace Type:
Office
Our Approach to Office Workplace Type
Certain positions outside our branch network may be eligible for a flexible work arrangement. We're combining the best of both worlds: in-office and work from home. Our approach enables our teams to deepen connections, maintain a strong community, and do their best work. Remote roles will also have the opportunity to come together in our offices for moments that matter. Specific work arrangements will be provided by the hiring team.
Huntington will not sponsor applicants for this position for immigration benefits, including but not limited to assisting with obtaining work permission for F-1 students, H-1B professionals, O-1 workers, TN workers, E-3 workers, among other immigration statuses. Applicants must be currently authorized to work in the United States on a full-time basis.
Compensation Range:
$70,000- 140,000 annual salary
The compensation range represents the low and high end of the base compensation range for this position. Actual compensation will vary and may be above or below the range based on various factors including but not limited to location, experience, and performance.  Colleagues in this position are also eligible to participate in an applicable incentive compensation plan.  In addition, Huntington provides a variety of benefits to colleagues, including health insurance coverage, wellness program, life and disability insurance, retirement savings plan, paid leave programs, paid holidays and paid time off (PTO).
Huntington is an Equal Opportunity Employer.
Tobacco-Free Hiring Practice: Visit Huntington's Career Web Site for more details.
Note to Agency Recruiters: Huntington will not pay a fee for any placement resulting from the receipt of an unsolicited resume. All unsolicited resumes sent to any Huntington colleagues, directly or indirectly, will be considered Huntington property. Recruiting agencies must have a valid, written and fully executed Master Service Agreement and Statement of Work for consideration.

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Limited Services Quality Assurance Coordinator

44101 Cleveland, Ohio Maximus

Posted 11 days ago

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Job Description

Permanent

Description & Requirements

Maximus is currently hiring a Limited Services Quality Assurance Coordinator to support our CA Lifeline team. This is a temporary remote position for candidates with Quality Assurance/Quality Control experience.
This role is pivotal in evaluating and improving the quality of work, ensuring alignment with project standards and contractual requirements. With a focus on quality performance monitoring and research, you'll contribute to the development of strategies for enhanced customer satisfaction and waste, fraud and abuse investigation. Your commitment to meeting standards and fulfilling assigned duties will be integral to the team's success.

At Maximus we offer a wide range of benefits to include:

- Work/Life Balance Support - Flexibility tailored to your needs

- Competitive Compensation - Bonuses based on performance included

- Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance.

- Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching.

- Paid Time Off Package - Enjoy paid time off, Holidays, and extended sick leave, along with Short and Long Term Disability coverage.

- Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP).

- Recognition Platform - Acknowledge and appreciate outstanding employee contributions.

- Tuition Reimbursement - Invest in your ongoing education and development.

- Employee Perks and Discounts - Additional benefits and discounts exclusively for employees.

- Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs.

- Professional Development Opportunities - Participate in training programs, workshops, and conferences