This role is responsible for managing and overseeing the Quality Systems to ensure compliance with regulations like ISO13485 and 21 CFR Part 820
Job Summary
This role is responsible for managing and overseeing the Quality Systems to ensure compliance with regulations like ISO13485 and 21 CFR Part 820.
The position requires supervising a team to conduct investigations into complaints, non-conformities, and corrective preventive actions while maintaining robust quality standards.
Candidates must have significant experience in the medical devices industry with a proven track record of leading audits and driving continuous improvement projects.
Matching Summary
This role is responsible for managing and overseeing the Quality Systems to ensure compliance with regulations like ISO13485 and 21 CFR Part 820.
Skills & Requirements
Must-have
5+ years medical devices industry experience
ISO13485 and 21 CFR Part 820 knowledge
CAPA and complaint investigation management
Internal and external audit leadership
Trend analysis and root cause analysis
Nice-to-have
Experience leading front or back room audits
Local registration submission experience
QMS regulated software proficiency
Change control principles expertise
Self-directed leadership with minimal supervision
Key Requirements
Bachelor's degree in industrial engineering or related field
5+ years experience in medical devices industry
1 year experience in management positions (preferred)