Quality Assurance Manager
vor 1 Monat
Responsibilities
- Ensuring the quality requirements for the production of medical devices as well as the associated technical documentation in accordance with ISO13485, MDR, CFR Part 820, product-specific standards, national guidelines and laws for the entire product lifecycle in the area of responsibility
- Coordination and processing of change control projects and maintenance of the associated documentation as well as coordination and processing of CAPAs in the area of responsibility
- Review and approval of documents in the lifecycle process (DMR, DHR)
- Contact person for stakeholders from the areas of production, development, and quality organization
- Support and participation in authority, customer and supplier audits and processing of audit findings
- Responsible for cleanroom support, including cleanroom monitoring and cleanroom training of internal and external personnel
- Organization and evaluation of product improvement data
- Completed technical or scientific studies (HF, Uni, FH)
- Several years of experience in a comparable role in the field of medical devices, pharmaceuticals or healthcare.
- Knowledge in relevant quality methods (statistical methods, FMEAs, Lean Six Sigma, risk-based decision-making, etc.)
- Self-initiative and service-oriented
- Fluent in German and English
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