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.

• 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
• 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:

• Collaborate with manufacturing engineering to develop a strategy for process assurance activities related to new product launch – review / approve process assurance documents (IQ’s, OQ’s, PQ’s, VE’s, 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 (PFMEA’s)
• Direct the resolution of quality issues by fostering cross-functional partnerships through effective communication, engagement activities, and influencing behaviors