6,749 Product Quality jobs in the United States

Hayward Holdings Inc. (NYSE: HAYW) is a global leader in innovative pool and spa equipment, designing and manufacturing high-performance solutions that enhance water experiences. As the world's largest manufacturer of residential swimming pool equipment, we continue to expand our presence in the commercial pool market. Headquartered in Charlotte, North Carolina, Hayward operates facilities across the U.S., Canada, Spain, France, Australia, and China. This role is based in Clemmons, NC.

We are seeking a Product Quality Assurance Engineer to lead root cause investigations, drive corrective and preventive actions (CAPA), and enhance product reliability. This role plays a key part in ensuring product quality, improving customer satisfaction, and reducing warranty costs. You will work cross-functionally with design, quality, manufacturing, and technical service teams to identify failure mechanisms and implement robust solutions.

• Conduct detailed failure investigations to determine root causes of product or component issues.
• Perform root cause analysis (RCA) using methodologies such as 8D, Fishbone, and FMEA.
• Collaborate with field service teams to gather failure data, assess trends, and provide technical insights.
• Partner with design and manufacturing teams to recommend and implement product design improvements and process enhancements.
• Support the transition of new or improved products from design to manufacturing.
• Develop and implement corrective and preventive actions (CAPA) to mitigate future failures.
• Analyze warranty claims to identify systemic issues and provide data-driven insights.
• Utilize testing, teardown analysis, and material characterization techniques to evaluate failed components.
• Document findings and present technical reports with actionable recommendations to leadership and stakeholders.
• Drive continuous improvement initiatives to enhance product durability and reliability by integrating lessons learned into the development process.

• Bachelor's degree in Mechanical Engineering or a related field (or equivalent work experience).
• 3+ years of experience in failure analysis, reliability engineering, or process engineering, preferably in a manufacturing environment.
• Strong understanding of mechanical, electrical, and hydraulic systems.
• Hands-on experience with disassembly, testing, and inspection of mechanical and electrical components.
• Proven problem-solving skills with the ability to lead cross-functional teams.
• Experience with root cause analysis methodologies and reliability testing.
• Knowledge of Advanced Product Quality Planning (APQP) methodologies.
• Proficiency in data analysis, statistics, and failure reporting tools (Power BI, Tableau).
• Excellent communication skills for technical reporting and presentations.
• Familiarity with CAD software and product lifecycle management (PLM) systems.
• Shainin or Lean Six Sigma Green Belt/Black Belt certification is a plus.

At Hayward, we are committed to quality, innovation, and sustainabilitydelivering solutions that inspire happiness and well-being. If you're passionate about solving complex problems and driving product excellence, we invite you to join our team!

In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivaled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes.

We are looking for a Quality Lead who brings a diversity of thinking and technical experience in pharmacovigilance / drug safety. The Quality Lead will support the Roche/Genentech Organization through the design and delivery of pharmacovigilance related quality strategies. Quality strategies will have defined quality measures (critical to quality (CtQ) factors) and objectives based on business surveillance and the use of data analytics. The Quality Lead will generate evidence and actionable data through the conduct of audits to assess the quality status and to be able to demonstrate effective implementation of quality assurance to stakeholders and Health Authorities.

Key Responsibilities

• Define process/affiliate level approach with appropriate measures (CtQ factors) to enable oversight and management of quality

• Design and implement quality strategies

• Assess specific risk areas on an ongoing basis, communicate to PDQ senior leadership and propose modifications to the quality strategy where necessary

• Actively lead or contribute in activities to assess quality status, including preparation, conduct, presentation and timely reporting of outcomes of audits, ensuring appropriate action plans are developed

• Establish strong partnerships/relationships with business stakeholders

• Prepare and present contextualized quality evidence, including conclusions, observations and associated compliance risks to business stakeholders and Pharma representatives

• Lead or support inspection preparation activities and management of Health Authority inspections

Your Profile

• You are a highly motivated and committed professional with strong experience and technical knowledge in pharmacovigilance.

• You have proven critical thinking and problem solving skills (curiosity, creativity and adaptability), with solid relationship management and influence. You ask the challenging questions and are comfortable in difficult conversations.

• You have an in-depth understanding of the drug development process.

Required

• Masters, Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience

• Minimum 5 years in the pharmaceutical industry and/or pharmacovigilance experience

• Demonstrated applied knowledge of pharmacovigilance / drug safety and regulatory requirements

• Demonstrated excellent analytical, strategic thinking, and problem-solving skills with a proven ability to understand business impact

• Excellent verbal and written communication and stakeholder management skills

• Project management experience with proven leadership, mentoring and coaching

Desired

• Proficiency in the conduct of GxP audits

• Experience supporting Health Authority inspections

• Proficiency in utilizing data and visualisation tools to generate insights

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $111,000 to $206,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .

Date Posted:2025-06-10Country:United States of AmericaLocation:FL410: Largo FL MFG 7887 Bryan Dairy Road , Largo, FL, 33777 USAPosition Role Type:OnsiteU.S. Citizen, U.S. Person, or Immigration Status Requirements: U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract.Security Clearance: None/Not RequiredRaytheon Company Managed by Collins AerospaceCollins Aerospace Mission Systems organization, where we're working side-by-side with customers on exciting industry possibilities. With a comprehensive portfolio, extensive capabilities, and broad expertise, we're crafting intelligent solutions to meet the demands of a rapidly evolving global market - all representing the best in innovation and technology for the industries we serve across commercial, business, space, and military and defense aviation.1st Shift Schedule: This position is for 1st shift with flexibility to work on 2nd shift. Monday - Friday 7:00 AM - 3:30 PM What You Will Do Inspects parts, subassemblies, units, modules, completed units, and/or sets to determine conformance to blueprints, drawings, specifications, inspection instructions, operation sheets, directives, checklists, Workmanship Quality Standards, Standard Practice Instructions, Purchase Orders, Quality Assurance Bulletins and other written or verbal instructions. Products inspected may be new build or customer returns. Determines acceptability, locates and records discrepancies on various types of subassemblies; standard, microelectronic and/or hi-rel; using routine inspection tools, direct reading instruments, gauges, meters, measuring devices such as continuity meters, specialized mechanical or optical measuring or testing devices and/or stereo microscopes. Inspects shippable items for identification, condition, and compliance to blueprints, specifications, operation sheets, general orders and other written or verbal instructions, using standard inspection tools and measuring devices. Collects data, prepares and maintains inspection records, using either written or electronic media, as required and/or directed by supervision. Moves material as directed and works with minimum supervision. Trains others in workmanship and product quality standards through an on-the-job training process as it relates to specific inspection requirements. May be involved in storing, use and disposal of hazardous waste chemicals such as acids, caustics, flammables, poisons and oxidizers in accordance with federal, state and local environmental protection laws. May be retrained annually to comply with applicable state and federal regulations. Employees may be required to obtain the appropriate government security clearance. Must be able to lift up to 28 pounds. Qualifications You Must Have: Typically requires HS diploma (or equivalent, e.g. G.E.D.) Requires one of the below requirements or successful completion of a pre-qualification inspection test 1 year of experience as a Quality Inspector, in the Electronics Manufacturing Industry. Active Quality Inspector Certification CQI by ASQ and 1 year of related work experience. 1 year of military experience, in Electronics Quality Inspection, as defined by the company. Electronics Certificate, by an accredited institution Must be able to pass a visual acuity (near and far vision) exam; color perception exam; depth perception exam; and/or additional company or contract requirements. Qualifications We Prefer: Associate or bachelor's degree in science, Technology, Engineering and Mathematics. What We Offer: Medical, dental, and vision insurance Three weeks of vacation for newly hired employees Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option Tuition reimbursement program Student Loan Repayment Program Life insurance and disability coverage Optional coverages you can buy pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection Birth, adoption, parental leave benefits Ovia Health, fertility, and family planning Adoption Assistance Autism Benefit Employee Assistance Plan, including up to 10 free counseling sessions Healthy You Incentives, wellness rewards program Doctor on Demand, virtual doctor visits Bright Horizons, child and elder care services Teladoc Medical Experts, second opinion program And more! Learn More & Apply Now!Collins Aerospace, a Raytheon Technologies company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market.Do you want to be a part of something bigger? A team whose impact stretches across the world, and even beyond? At Collins Aerospace, our Mission Systems team helps civilian, military and government customers complete their most complex missions - whatever and wherever they may be. Our customers depend on us for intelligent and secure communications, missionized systems for specialized aircraft and spacecraft and collaborative space solutions. By joining our team, you'll have your own critical part to play in ensuring our customers succeed today while anticipating their needs for tomorrow. Are you up for the challenge? Join our mission today.*Please ensure the role type (defined below) is appropriate for your needs before applying to this role.Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window.RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Privacy Policy and Terms:Click on this link to read the Policy and Terms

Product Quality Engineer

POSITION OVERVIEW

We are seeking a Product Quality Engineer to join our dynamic team. In this role you will observe and advise daily factory floor quality activities to support production, function as a liaison between suppliers and customers, and define the methods and equipment used to measure key quality characteristics.

WHAT YOU WILL DO

• Handle customer QA issues, prepare 8Ds and communicate solutions to customers in a timely manner
• Lead PPM improvement plan for strategic customers
• Develop and submit PPAP documents for new product lunches to meet customer requirements
• Maintain Control Plans and FMEA's throughout the life of the part
• Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes
• Collaborates with Manufacturing, Engineering, Supply Chain and other departments to analyze and resolve non conformance (DMR) issues
• Update plant and corporate metrics monthly.
• Support implementation of corrective actions for customer complaints
• Monitor/analyze production performance trends for key quality metrics and establish appropriate control measures
• Perform robust root cause analysis of production issues, implements appropriate containment, and drives corrective action
• Establish statistical confidence by identifying sample size and acceptable error; determining levels of confidence
• Drive detection and prevention of non conformances to eliminate failure modes and improve business results through reductions in scrap and rework costs in addition to assurance of a positive customer experience
• Evaluate and improves quality inspection methods and fixtures to improve reliability and repeatability of incoming, in-process, and final QC
• Drive continuous improvement through the implementation of projects which optimize production, inspection, and quality system processes
• Supply targets for yield improvements
• Provide additional support for Quality activities and duties as assigned

WHAT WE REQUIRE

• College degree
• Minimum 3 years of experience in an manufacturing environment.
• Positive attitude and ability to operate and communicate effectively with customers, multiple teams & leadership.
• Practical experience of customer corrective actions methodologies as 8D, 7D, 5 phases etc.
• Attention to detail and problem solving skills.
• Statistical process control skills including capability studies and Gauge R&R
• Working knowledge of the AIAG Core Tools (PPAP, SPC, APQP, FMEA, MSA);
• Experience of Root Cause Analysis and Corrective/Preventive Actions

WHAT WE PREFER

• Lean manufacturing
• Stamping, machining and/or plating
• Certified ISO/TS16949 Internal Auditor
• Six Sigma
• Advanced understanding of engineering drawings, plant layouts
• Advanced process error proofing skills

WHAT WE OFFER

• Taking Care of our Employees with Medical, Dental, Vision, Life and Disability Insurance coverage options.
• Your health is our priority, we offer Medical Wellness Programs to aid in your well-being.
• Vacation and Personal Time Off
• We support your growing family; we provide Parental Leave for Moms and Dads!
• Wisely plan for your future with our 401k Matching plan beginning on Day One.
• Supporting your career development with our Tuition Reimbursement Program.
• Robust culture supporting internal advancement with our Learn and Grow Program.
• 24/7 access to over 15,000 LinkedIn Learning courses to assist in your professional development and to expand on your individual interests.
• Employee Assistance Programs
• Unlimited Referral Reward Bonuses
• Corporate Discounts for shopping, travel and more!

WHY JOIN DORMAKABA?

Advanced Diagnostics, Ilco and Silca, comprise the Key Systems business unit of the parent Group dormakaba. Key Systems is the global leader in the Locksmithing and Automotive locksmithing industry and first key- blanks manufacturer, providing to our customers worldwide the latest technology and an outstanding know how. The uniquely extensive range of products and solutions - such as vehicle keys cloning and programming devices, residential keys' duplication solutions, key machines for professionals - is distributed in more than 130 countries, with a tailored presence of our three leading brands by channel and country.

Date Posted:2025-04-28Country:United States of AmericaLocation:FL410: Largo FL MFG 7887 Bryan Dairy Road , Largo, FL, 33777 USAPosition Role Type:OnsiteU.S. Citizen, U.S. Person, or Immigration Status Requirements: U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract.Security Clearance: None/Not RequiredRaytheon Company Managed by Collins AerospaceCollins Aerospace Mission Systems organization, where we're working side-by-side with customers on exciting industry possibilities. With a comprehensive portfolio, extensive capabilities, and broad expertise, we're crafting intelligent solutions to meet the demands of a rapidly evolving global market - all representing the best in innovation and technology for the industries we serve across commercial, business, space, and military and defense aviation.1st Shift Schedule:This position is for 1st shift with flexibility to work on 2nd shift.Monday - Friday 7:00 AM - 3:30 PMWhat You Will DoInspects parts, subassemblies, units, modules, completed units, and/or sets to determine conformance to blueprints, drawings, specifications, inspection instructions, operation sheets, directives, checklists, Workmanship Quality Standards, Standard Practice Instructions, Purchase Orders, Quality Assurance Bulletins and other written or verbal instructions.Products inspected may be new build or customer returns.Determines acceptability, locates and records discrepancies on various types of subassemblies; standard, microelectronic and/or hi-rel; using routine inspection tools, direct reading instruments, gauges, meters, measuring devices such as continuity meters, specialized mechanical or optical measuring or testing devices and/or stereo microscopes.Inspects shippable items for identification, condition, and compliance to blueprints, specifications, operation sheets, general orders and other written or verbal instructions, using standard inspection tools and measuring devices.Collects data, prepares and maintains inspection records, using either written or electronic media, as required and/or directed by supervision.Moves material as directed and works with minimum supervision.Trains others in workmanship and product quality standards through an on-the-job training process as it relates to specific inspection requirements.May be involved in storing, use and disposal of hazardous waste chemicals such as acids, caustics, flammables, poisons and oxidizers in accordance with federal, state and local environmental protection laws.May be retrained annually to comply with applicable state and federal regulations.Employees may be required to obtain the appropriate government security clearance.Must be able to lift up to 28 pounds.Qualifications You Must Have: Typically requires HS diploma (or equivalent, e.g. G.E.D.)Requires one of the below requirements or successful completion of a pre-qualification inspection test1 year of experience as a Quality Inspector, in the Electronics Manufacturing Industry.Active Quality Inspector Certification CQI by ASQ and 1 year of related work experience.1 year of military experience, in Electronics Quality Inspection, as defined by the company.Electronics Certificate, by an accredited institutionMust be able to pass a visual acuity (near and far vision) exam; color perception exam; depth perception exam; and/or additional company or contract requirements.Qualifications We Prefer: Associate or bachelor's degree in science, Technology, Engineering and Mathematics.What We Offer:Medical, dental, and vision insuranceThree weeks of vacation for newly hired employeesGenerous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy optionTuition reimbursement programStudent Loan Repayment ProgramLife insurance and disability coverageOptional coverages you can buy pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protectionBirth, adoption, parental leave benefitsOvia Health, fertility, and family planningAdoption AssistanceAutism BenefitEmployee Assistance Plan, including up to 10 free counseling sessionsHealthy You Incentives, wellness rewards programDoctor on Demand, virtual doctor visitsBright Horizons, child and elder care servicesTeladoc Medical Experts, second opinion programAnd more!Learn More & Apply Now!Collins Aerospace, a Raytheon Technologies company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market.Do you want to be a part of something bigger? A team whose impact stretches across the world, and even beyond? At Collins Aerospace, our Mission Systems team helps civilian, military and government customers complete their most complex missions - whatever and wherever they may be. Our customers depend on us for intelligent and secure communications, missionized systems for specialized aircraft and spacecraft and collaborative space solutions. By joining our team, you'll have your own critical part to play in ensuring our customers succeed today while anticipating their needs for tomorrow. Are you up for the challenge? Join our mission today.*Please ensure the role type (defined below) is appropriate for your needs before applying to this role.Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window.RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Privacy Policy and Terms:Click on this link to read the Policy and Terms

• Read and interpret drawings, diagrams, blueprints, specifications, purchase order, customer orders, work orders, Travelers, Test Reports
• Inspection of electronic equipment with its sub-assemblies like circuit cards, power supplies, wire harnesses, chassis assemblies, final unit assemblies for compliance with engineering drawings, customer requirements, Customer Order, FAA, ISO/AS9100 and other regulatory agency requirements
• Inspect to workmanship standard and acceptance criteria for electrical/electronic assemblies or electronic systems or support structures and components, units, subassemblies, wiring, or assembly casings, using rivets, bolts, crimps, stakes, screws, welds, solders, press fits, or performs similar operations to join or secure parts in place
• Inspect dimensions and clearances of parts for conformance to drawing, specifications, using instruments, such as micrometers, calipers, feeler gauges, height gauges, and other quality inspection tools.
• Performing/Reporting First Article Inspection (FAI) and issue FAI reports per AS9102B, include per Geometric Dimensioning and Tolerancing (GD&T) ASME Y14.5-2009 requirements
• Working knowledge of or certified in IPC-A-600, IPC-A-610, IPC-A-620 workmanship Standard
• Inspect Test Reports to ensure conformance to test specifications
• Verify configuration level for hardware and software products
• Pull together Conformity data-package for unit shipment, or to present to show customer product/process requirement conformance
• Familiar with assembly methods and processes of electronic units in an ISO-9001 / AS9100 manufacturing environment
• Must be able to document inspection findings, complete rejection reports communicate inspection findings and concerns with manufacturing and other Quality personnel as well as understand and follow written company procedures and processes

• Ethical conduct - Will treat everyone with respect, inspires the trust of other, follows policies and procedures and supports organization's goals and values.
• Stress Management/Composure - Ability to perform under pressure and demonstrate tact and composure.
• Problem Solving - Identifies and resolves problem in a timely manner, demonstrates problem solving and troubleshooting skills.
• Technical Capacity.
• Communication Proficiency - Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
• Analytical Skills - Skill and ability to: collect, organize, synthesize, and analyze data, summarize findings; develop conclusions and recommendations from appropriate data sources.
• Collaboration - Works effectively and cooperatively with others; establishes and maintains good working relationships.
• Customer Focus - Makes customers and their needs a primary focus on one's actions; develops and sustains productive customer relationships.
• Performance Management.
• Results Driven.
• Diversity - demonstrate knowledge of company EEO policy and promotes and harassment-free environment.

• Proficient in Microsoft Office Applications: Outlook, Windows, Word, Excel, Access

• Current IPC-610 or IPC-620 certification strongly preferred

• Minimum 5 years' experience in the inspection of avionics units or electronic equivalent systems.
• Proficiency in using calipers, micrometers, scales, PC-Windows experience and accuracy in data entry.
• Maintained knowledge in IPC-610 or IPC-620 workmanship STD.

• U.S. Person required due to ITAR restrictions

• This is a full-time position, and hours of work and days are Monday through Friday within one hour plus/minus of 6.30 a.m. to 4:00 p.m. This position may require long hours and frequent weekend work.

• Develop and maintain strong internal working relationships across Conformis.
• Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
• Prioritize and plan work activities; adapt for changing conditions.
• Perform quality testing of CER and Purified water system.
• Perform product release activities (on an as needed basis).
• Administers the bioburden/endotoxin testing program as required per procedure.
• Trend in-process manufacturing data and environmental monitoring data and produce summary reports.
• Implement and maintain quality system in accordance to applicable regulatory requirements.
• Initiate and participate in resolution of non-conforming materials.
• Review Non-Conformity Reports for sub-assemblies and finished goods.
• Administer the calibration system.
• Review of the daily activities for production start-up.
• Develop and upgrade procedures for continuous improvement as required by the quality system.
• Perform Internal Quality Audits of the quality system.
• Develop qualification/validation plans.
• Conduct product/process validations (sterilization).
• Develop and implement statistical sampling plans.
• Assist in the investigation of product complaints.
• Assist in corrective action investigations.
• Perform internal audits to drive continuous improvement (minimum of 2 per year).
• Other responsibilities as assigned.

• Bachelor of Science in Engineering or Science.
• 1-3 years of Quality Assurance/Quality Engineering and experience in a FDA regulated environment is preferred - with QSR (21 CFR Part 820) experience if possible (Job Specific Qualifications).

• Excellent written and verbal communication skills.
• Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
• Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
• Strong organizational, analytical, and time-management skills.
• Able to self-motivate and work both independently and as part of a team.
• Must have a solid knowledge of Microsoft office 2010.
• Knowledge of FDA and ISO standards for Medical Devices is a plus.
• Knowledge of Statgraphics or Minitab is a plus.