Urgent! Quality Engineer II Job Opening In Utica – Now Hiring ConMed
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 is a supporting process within the manufacturing process.
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).
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%
Disclosure as required by applicable law, the annual salary range for this position is $70,480 to $109,768.
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.
This job posting is anticipated to close on November 7, 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 for more information.
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!
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Unlock Your Quality Engineer Potential: Insight & Career Growth Guide
Real-time Quality Engineer Jobs Trends in Utica, United States (Graphical Representation)
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Great news! ConMed is currently hiring and seeking a Quality Engineer II to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Quality Engineer II Jobs Utica.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at ConMed adheres to the cultural norms as outlined by Expertini.
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