Provide Quality Engineering support for combination products, molding, assembly and automated manufacturing lines, and medical device operations.
Requirements
- 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.
- 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.
Benefits
- An innovative, vibrant and agile culture
- Growth opportunities in a globally successful and dynamic business on a growth trajectory
- Excellent employee benefits including: Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability
- Employee Savings Plan / 401k with 100% employer match
