Operational leader coordinating departments and driving business execution at Six Values. Ensuring alignment and clarity of business priorities across multiple teams.
About the role
- Quality Manager ensuring ISO 13485 compliance at healthcare company. Responsible for quality management processes, audits, and training in operations.
Responsibilities
- Ensure compliance with quality standards (ISO 13485, GMP, medical device regulations) in collaboration with Operations
- Manage deviation, CAPA and complaint processes, including root cause analysis and effectiveness checks
- Conduct and support internal audits and assist with external audits and inspections
- Approve serial line releases in coordination with Quality & Regulatory
- Implement production-relevant changes as part of change control management
- Provide technical guidance and coaching to the "Quality on the Shopfloor" team
- Plan, organize and deliver training on quality topics for production staff
- Actively contribute to new projects and continuous process optimization
Requirements
- Successfully completed technical or scientific degree or equivalent vocational training with several years of professional experience
- Several years of hands-on experience in quality management/operations, ideally in the medical device or pharmaceutical industry or primary packaging production
- Solid knowledge of relevant standards and regulations (ISO 13485, MDR/IVDR awareness, GMP)
- Practical experience with CAPA, FMEA and root cause analysis methods, as well as change control
- Hands-on experience leading and motivating cross-functional teams
- Analytical thinking and experience with quality metrics
- Very good German and good English skills, both written and spoken
Benefits
- 30 days of vacation
- Flexible working hours
- Option for remote/mobile work
- Diverse health and wellness offerings
- Bike leasing
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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