Quality Engineer

EPM Scientific; Freiburg im Breisgau; Vor Ort; EUR 60.000 - 68.000; Vollzeit

Zusammenfassung

EPM Scientific is seeking an experienced Quality Engineer to strengthen the Quality Systems for a leading medical device organisation. The role focuses on maintaining and improving the QMS, CAPA handling, RCA investigations, and collaboration with Quality, Regulatory, Engineering and Operations teams.

The contract is 9-12 months with a strong likelihood of extension and requires on-site presence. The ideal candidate will have 2-3 years of medical device quality experience, solid ISO 13485

Qualifikationen

• Minimum 2-3 years of quality experience in medical devices or other highly regulated industries.
• Strong knowledge of ISO 13485 and Quality Management Systems.
• Hands-on experience with CAPA, RCA, non-conformances and audits.
• Knowledge of EU MDR, FDA QMSR and/or MDSAP advantageous.

Aufgaben

• Maintain and improve the Quality Management System (QMS).
• Manage CAPAs, non-conformances and change controls.
• Lead and support Root Cause Analysis (RCA) and investigations.
• Support internal, external and regulatory audits.
• Review and maintain SOPs and quality documentation.
• Monitor quality metrics and identify continuous improvement opportunities.
• Support document control, training and compliance activities.
• Partner with Quality, Regulatory, Engineering and Operations teams.

Kenntnisse

Quality Management

CAPA / Corrective Actions

Root Cause Analysis (RCA)

Audits

Quality documentation

ISO 13485 Knowledge

EU MDR / FDA QMSR awareness

Stakeholder management

Jobbeschreibung

9-12 Month Contract with potential extension

4+ Days On-Site

We're supporting a leading global medical device organisation looking for an experienced Quality Engineer with a strong focus on Quality Systems to join their team on an initial 9-12 month contract, with a higher potential for extension.

This is a predominantly on-site position, requiring at least 4 days per week on site.

What You'll Do

• Maintain and continuously improve the Quality Management System (QMS)
• Manage CAPAs, non-conformances and change controls
• Lead and support Root Cause Analysis (RCA) and investigations
• Support internal, external and regulatory audits
• Review and maintain SOPs and quality documentation
• Monitor quality metrics and identify continuous improvement opportunities
• Support document control, training and compliance activities
• Partner with Quality, Regulatory, Engineering and Operations teams

What We're Looking For

• A minimum of 2-3 years of quality experience within medical devices or another highly regulated industry
• Strong knowledge of ISO 13485 and Quality Management Systems
• Hands-on experience with CAPA, RCA, non-conformances and audits
• Knowledge of EU MDR, FDA QMSR and/or MDSAP advantageous
• Strong communication, problem-solving and stakeholder management skills