Quality Systems Engineer
vor 1 Woche
Our client are a world-leading developer and manufacturer of innovative medical technology and devices. They have global presence and offer a wide range of surgical products, brand as well as private-label products.
Since 2019, the group has made several acquisitions across the UK and Europe. Products are sold worldwide through a network of multinational or regional partners and distributors, as well as through direct sales. The group has R&D innovation centers looking to continually innovate.
They are looking to add a Quality Systems Engineer to the team base in Bavaria, Germany to ensure compliance.
Position:
- Prepare and support in the execution of external audits by Notified Bodies
- Conduct and follow-up of internal audits
- Training colleagues on quality topics, updated SOPs, and GMP requirements
- Creation and updating of QMS SOPs as well as supporting other departments (including across locations)
- Participation in quality management projects (e.g., implementation of MDR requirements, group-wide SOPs, country-specific MDSAP requirements)
- The Quality Systems Engineer will support and represent in change & CAPA processes
- Participation in Non-Conformity and Complaints
- Support Group Regulatory Affairs in the product registration of medical devices, especially within the scope of the MDR but also worldwide
- Independent data collection and analysis, e.g., for approval purposes
- Support of new product development in (quality)
Qualifications:
- The Quality Systems Engineer will ideally have a Degree level education or track record in Quality Systems
- Production Site Exposure in medical device, pharmaceuticals, or GxP sectors
- Knowledge of ISO 13485, MDD, MDR, and MDSAP
- CAPA, non-conformance, and complaint handling
- Ideally training as an internal auditor
- German & English Language & Writing skills
Desirable:
- Knowledge in risk management (ISO 14971)
- Change control
This is a fixed term contractbetween 12-24 months
Desired Skills and Experience
Quality Systems, medical device, ISO 13485, MDD, MDR, and MDSAP, CAPA, non-conformance, and complaint handling, auditing, German & English
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