Quality Engineer II

As a Quality Engineer II at CONMED, you will collaborate cross-functionally to support the production factories, lines, and cells during the manufacture of CONMED medical devices. The QE 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.

** This role has the opportunity to be releveled to a higher level**

Key Duties and Responsibilities:

• Develop, Implement, and maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. (EN IS13485/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.

Requirements

• Bachelor's degree in Engineering or related technical, science-based degree

• 2+ years of engineering experience in medical device or highly regulated industry.

Strongly Preferred:

• Industry experience within regulated environments such as medical devices, biotechnology, or pharmaceuticals, with a solid understanding of compliance and quality standards. Excellent communication skills, with the ability to effectively engage with individuals at all levels of the organization, both vertically and cross-functionally.

• Strong analytical and organizational capabilities, with proven expertise in problem-solving, critical thinking, strategic planning, and effective time management.

• Knowledge of quality principles, systems, methods, problem-solving tools, and statistical principles

• General understanding of 21CFR820 / ISO13485 / ISO14971

• Actively pursuing professional certifications such as Certified Quality Engineer (CQE), Lean Six Sigma Black Belt, or equivalent, reflecting a commitment to continuous improvement and professional development.

This position is not open to employer based sponsorship.

Travel 0-20%

This job posting is anticipated to close on November 3, 2025. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.

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? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!

CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms 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.