Quality Engineer II

CONMED • Largo, FL

72d

About The Position

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.

Requirements

• Bachelor's degree in Engineering or related technical, science-based degree.
• 2+ years of engineering experience in medical device or highly regulated industry.

Nice To Haves

• 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.

Responsibilities

• Understand and follow all CONMED policies; follow standards for safe behaviors; deploy the CONMED Pillars while executing the role.
• Develop, Implement, and maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. (ISO 13485 / EU MDR & 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), Root Cause Analysis, Capability Analysis, Gage Repeatability & Reliability (Gage R&R), Design of Experiment (DOE), etc., 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.
• 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 and CAPA management, complaint trending and manufacturing contribution investigation, ensure that product on hold is dispositioned in a timely manner, change management and document approval, quality objectives management through data analysis that supports the ConMed Operating System / Tier process and driving a continuous improvement culture, statistical analysis, and training / consulting on quality concepts, quality technology tools, and investigation techniques.
• Support new product introductions through the design transfer activities including but not limited to collaborating with manufacturing engineering to develop a strategy for process assurance activities related to new product launch, reviewing / approving process assurance documents (IQ's, OQ's, PQ's, VE's, Test Method Validations), reviewing / approving change notices associated with the introduction of process documentation related to new product launch, collaborating with manufacturing engineering / R&D to develop process risk documents (PFMEA's), and directing the resolution of quality issues by fostering cross-functional partnerships through effective communication, engagement activities, and influencing behaviors.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees