We are seeking a Quality Management System (QMS) Manager to lead and enhance our audit program, ensuring compliance with regulatory standards in the medical device industry. If you have expertise in audit program management and hosting external audits, we want to hear from you!
Key Responsibilities:
- Develop, implement, and manage the internal and external audit program
- Host and lead external audits with regulatory bodies, notified bodies, and customers
- Ensure compliance with FDA, ISO 13485, MDSAP, and EU MDR requirements
- Drive audit readiness strategies, corrective actions, and continuous improvements
- Collaborate cross-functionally to resolve audit findings and enhance QMS effectiveness
Qualifications:
- Bachelor's degree in Engineering, Quality, or a related field
- 5+ years of experience in QMS, auditing, and compliance within the medical device industry
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, MDSAP, and EU MDR
- Experience in leading and hosting external audits with regulatory agencies
- Excellent problem-solving, leadership, and communication skills
Why Join Us?
- Lead a high-impact audit program in a regulated industry
- Work in a collaborative and fast-paced environment
- Competitive salary, benefits, and career advancement opportunities
