Provide Quality Engineering support for combination products, molding, assembly and automated manufacturing lines, and medical device operations.
Ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable global regulatory requirements.
Participate in or lead risk management activities per ISO 14971, including DFMEA, PFMEA, hazard analyses, and control strategy development.
Own and maintain Quality System documentation including work instructions, specifications, and control plans.
Lead or support investigations for nonconformances, deviations, and customer complaints through root cause analysis using tools such as 5 Whys, Fishbone, Fault Tree Analysis, or DOE.
Develop and implement effective Corrective and Preventive Actions (CAPA); verify and validate effectiveness.
Monitor manufacturing risks and develop mitigation strategies focused on patient safety and product quality.
Lead compliance efforts for handling scheduled drug products.