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Manager quality engineering Jobs in Engstingen
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Manager quality engineering • engstingen
- Gesponsert
Senior Auditor Quality Assurance Manager (m / f / x)
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SciProBaden-Württemberg, Germany, GermanySenior Auditor Quality Assurance Manager (m / f / x) || Hessen || Medical Devices
Responsibilities :
- Lead audits for clinical trials and medical products to ensure compliance with GxP and regulatory standards.
- Develop and implement audit plans based on risk assessments and conduct internal process and vendor audits.
- Address and escalate serious clinical trial violations, ensuring timely resolution.
- Contribute to the development and maintenance of the Quality Management System (QMS), focusing on document management, CAPA, deviations, and SOPs.
- Advise the Clinical Operations team on CAPA management and quality-related issues.
- Provide independent consultation on GCP-related and quality issues within clinical research.
- Support the qualification process for clinical development suppliers and lead supplier audits.
- Train employees on best practices in GCP, GCLP, pharmacovigilance, and clinical trial regulations.
- Coordinate inspections and audits by regulatory authorities and ensure readiness for external audits.
- Manage CAPA actions from inspections and support regulatory compliance within R&D
Requirements :
About the Client :
This company offers a great working environment with a global perspective and the opportunity to work in an international team. The flexible hybrid model allows you to work 2 days in the office and 3 days remotely. With an average employee tenure of over 8 years, the company provides long-term stability and growth opportunities. In addition to a competitive salary, employees enjoy attractive benefits such as Wellpass, Jobticket, Jobbike, 39 vacation days, a pension plan, and childcare support.
If you're passionate about driving clinical trials forward in the field of medical devices, with a strong emphasis on cross-functional leadership, efficiency, and quality compliance, we encourage you to apply.
I´m looking forward to seeing your application!
Contact details :
E-Mail : [email protected]
Tel : 089 26 20 09 25