- City of Industry, California, United States
- $97K–$129K per year
- 5–10 years
The Quality Systems and Compliance Manager is responsible for developing, implementing, maintaining, and continually improving the Quality Management System (QMS) in accordance with ISO 9001:2015, ISO 13485:2016, applicable regulatory requirements, and EU Medical Device Regulation (MDR) 2017/745.
Compensation
Salary Range: $96,600.00-$128,800.000
Responsibilities
- Develop and maintain the QMS in compliance with ISO 9001, ISO 13485, EU MDR, and national regulations
- Serve as management representative or designated quality leader
- Monitor QMS performance through quality objectives, KPIs, trend analysis, and management review reporting
- Ensure compliance with medical device regulations including EU MDR and FDA Quality System Regulation
- Support regulatory inspections, audits, and certifications
Requirements
- Bachelor's degree in Engineering, Quality, Regulatory Affairs, Life Sciences, Manufacturing or related discipline
- Nice to have: Medical device industry experience
- Nice to have: ISO 13485 lead auditor certification
- Nice to have: ASQ Certified Quality Manager (CMQ/OE)
- Nice to have: Certified Quality Engineer (CQE)