Resintech, Inc.
Camden, NJ, USA
JOB DESCRIPTION: The Sr. Medical Device Quality Engineer serves as a technical leader as a cornerstone of our quality operations; you will drive compliance and continuous improvement across the filtration device product lines. Ensure our QMS and manufacturing processes meet the highest standards while leading cross-functional and intercompany teams to resolve complex quality challenges. Primary Responsibilities Regulatory Compliance: Safeguard product integrity and process compliance in strict accordance with FDA 21 CFR Part 820 and ISO 13485 standards. Ensure our QMS system meets customer requirements striving towards meeting medical device standards. (Not currently ISO13485) Quality Management: Direct the maintenance of internal QMS procedures and documentation to ensure audit readiness at all times. Serve as a key technical representative during internal and external regulatory audits. Root Cause Analysis: Lead technical investigations into product and process...
