Quality Systems Engineer III - Lead Auditor

The Quality Engineer III collaborates cross-functionally to support the production factories, lines and cells during the manufacturing process of CONMED medical devices. The Quality Engineer III supports operations with the objective of maintaining high quality standards for the product manufacturing process and the conformance to the CONMED Quality Management System and the regulatory requirements.

Key Duties & Responsibilities:

• Develop, Implement, and maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. (EN ISO 13485/CMDCAS/MDD & FDA QSR).
• Keep current on all applicable best practices and statutory regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices.
• Demonstrate leadership and initiative to plan and perform engineering assignments that support company goals and objectives.

• Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Tree Analysis (FTE), Root Cause Analysis, and Design of Experiment (DOE) to the development of new products or processes; and in solving process/product-related problems. Promote and apply the DMAIC/PDCA Methodology for product/process/system improvements.
• Direct and guide the Quality Technicians in the factory.
• Provide support to Operations on quality assurance/control issues including but not limited to: Day-to-day troubleshooting situations, Communication/escalation of key quality issues, NCR/NCP management, complaint management, CAPA management, change management, risk management, quality objectives management through data analysis, statistical analysis, and training/consultation on quality concepts, quality technology tools, and investigation techniques.
• Collaborate with manufacturing engineering to develop a strategy for process assurance activities related to new product launch - review/approve process assurance documents (IQs, OQs, PQs, VEs, Test Method Validations).
• Review/approve change notices associated with the introduction of process documentation related to new product launch (tooling drawings, work instructions, process travelers, control plans and inspection procedures).
• Collaborate with manufacturing engineering/R&D to develop process risk documents (PFMEAs).
• Review/approve Design Transfer Matrix (DTM) to ensure all critical product characteristics have been addressed prior to product launch.
• Direct the resolution of quality issues by fostering cross-functional partnerships through effective communication, engagement activities, and influencing behaviors.

Minimum Requirements:

• Bachelor's degree in Engineering or related technical discipline
• 5 years related experience in Quality Assurance or Quality Engineering with a bachelor's degree; 3 years with a master's degree.

Other Attributes:

• Thorough understanding of 21CFR820/ISO13485/ISO14971
• Knowledge of quality principles, systems, methods, problem-solving tools, and statistical principles

0-20% Travel

This position is not eligible for employer based sponsorship. Disclosure as required by applicable law, the annual salary range is 80,000-130,000. The actual compensation may vary based on geographic location, work experience, education and skill level. The salary range is CONMED's good faith belief at the time of this posting.

Benefits:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
• Employee Stock Purchase Plan -- allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses

Know someone at CONMED?

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CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status. The Know Your Rights: Workplace Discrimination is Illegal Poster and Pay Transparency Nondiscrimination Provision reaffirm this commitment.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.