Quality Systems Engineer

EPM Scientific; Regensburg; Vor Ort; EUR 55.000 - 70.000; Vollzeit

Zusammenfassung

A leading medical technology firm in Bavaria is seeking an experienced Quality Systems Engineer. This role involves ensuring compliance with regulations, preparing for audits, conducting internal audits, and training staff on quality standards. Ideal candidates should have a degree in Quality Systems and experience in the medical device sector. Proficiency in German and English is essential. Competitive salary and benefits are offered.

Qualifikationen

• Degree level education or track record in Quality Systems.
• Experience in medical device, pharmaceuticals, or GxP sectors.
• Knowledge of ISO 13485, MDD, MDR, and MDSAP.

Aufgaben

• Prepare and support execution of external audits by Notified Bodies.
• Conduct and follow-up of internal audits.
• Train colleagues on quality topics and requirements.
• Creation and updating of QMS SOPs.
• Participate in quality management projects.

Kenntnisse

Quality Systems

ISO 13485

MDD

MDR

MDSAP

CAPA

Complaint handling

Auditing

German Language

English Language

Ausbildung

Degree level education in Quality Systems

Jobbeschreibung

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

Desired Skills and Experience

Quality Systems, medical device, ISO 13485, MDD, MDR, and MDSAP, CAPA, non-conformance, and complaint handling, auditing, German & English