Title: Senior Manager Quality Management Systems
Job type: Permanent
Location: Germany
Salary: Competitive
Who is eager to take on a new challenge.
Your responsibilities will include, but are not limited to:
- Developing, managing and maintaining quality assurance procedures and activities to ensure compliance with applicable quality standards and applicable legal requirements (ISO 9001, ISO 13485, MDD 93/42 / EEC, MDR, etc.) in relation to our processes, products and systems
- Identification of recurring quality problems and assistance in resolving them; Carrying out root cause investigations and leading appropriate meetings for faulty materials and CAPAs.
Key requirements:
- Excellent knowledge of ISO 13485 and ISO 9001, the Medical Device Regulation (MDR), FDA Quality System Regulation, Good Manufacturing Practices (GMP) and applicable quality system standards (technical) bachelor / master degree
- At least 5 years of experience in field of activity with medical devices
- Experience as a lead auditor
- Experience in developing, implementing and revising quality systems
- Excellent written and oral English skills (subject-related)
- Excellent moderation skills, organizational skills and an analytical mindset
If you are interested in the role, apply online today, call +44 203 667 8385 or email your CV
