Quality Systems Engineer

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