This role involves maintaining and improving the QMS to ensure compliance with ISO 9001 and ISO 13485 standards within the medical device sector
Job Summary
This role involves maintaining and improving the QMS to ensure compliance with ISO 9001 and ISO 13485 standards within the medical device sector.
The successful candidate will manage internal and external audits, track findings, and lead corrective and preventive actions (CAPA) using a risk-based approach.
Candidates are expected to support the implementation of digital RA/QMS tools and ensure data integrity through Computer System Validation requirements.
Matching Summary
This role involves maintaining and improving the QMS to ensure compliance with ISO 9001 and ISO 13485 standards within the medical device sector.
Skills & Requirements
Must-have
ISO 13485 and ISO 9001 standards knowledge
3-5 years Quality Management experience
Regulated industry background required
CAPA process and risk assessment skills
Internal and external audit coordination
Nice-to-have
Lead Auditor certification preferred
German language fluency is a plus
Experience with digital quality systems
Computer System Validation (CSV) expertise
Trackwise or Veeva system familiarity
Key Requirements
Bachelor's or Master's degree in engineering or sciences
3-5 years experience in regulated industry quality management