Interim Quality Engineer

Unity Partners exclusively on behalf of our MedTech partner

Interim Quality Engineer | Rotterdam area (Hybrid)3 days per week | 3 to 6 months

Our partner is a manufacturer of medical devices used by hospitals and clinics worldwide. Operating in a regulated MDR and FDA environment, they are looking for an experienced Interim Quality Engineer to lead and complete a backlog of open CAPAs with a technical focus.

Role Overview

This is a focused, hands-on interim assignment. Your primary task is to independently lead and close CAPAs related to production control — think calibration, equipment approval processes and similar technical quality topics. You hit the ground running and know how to prioritise and deliver in a regulated environment.

Key Responsibilities

• Lead and complete CAPAs in line with ISO 13485:2016 and FDA QMSR requirements, including investigation, root cause analysis, action definition and effectiveness verification
• Prioritise open CAPAs and work through them systematically and independently
• Support other ad hoc technical quality matters as capacity allows

Your Profile

• Bachelor's or Master's degree in Mechanical or Industrial Engineering, or a related field
• Proven experience leading and completing CAPA investigations in an FDA medical device environment, including exposure to FDA inspection expectations
• Working knowledge of ISO 13485:2016, FDA QMSR and EU MDR 2017/745
• Precise, pragmatic and able to take initiative without hand-holding
• Excellent written and structuring skills in English; Dutch is a plus
• Available for at least one day per week on-site in the Rotterdam area

What is on offer

• A focused interim assignment with direct impact on patient safety and regulatory compliance
• Supportive team with short reporting lines
• Flexible and hybrid working arrangement
• 3 days per week, 3 to 6 months duration

Interested?Reach out to Christian Steenkamp via christian@unitypartners.nl | +31 (0)20 8938 606

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