Sr. QA Engineer

Unity Partners exclusively on behalf of our MedTech partner

Our partner is an established player in the medical device industry, developing innovative treatment solutions used by healthcare providers worldwide. With a dedicated focus on a specific product line within their broader portfolio, quality and regulatory compliance sit at the core of how they operate.

To strengthen their Quality team on a structural basis, we are looking for an experienced QA Engineer who can quickly operate independently and make a direct impact from day one.

Role Overview

As QA Engineer, you join a close-knit QA team, working closely alongside the RA team. These teams collaborate cross-functionally with Engineering, Sales & Marketing, Supply Chain and Manufacturing to keep products and processes aligned with current standards and regulations across the medical device industry. This is a permanent position.

Key Responsibilities

• Ensure product compliance for an assigned value stream within the product portfolio
• Support the local and global QMS and related processes
• Represent the QA organisation in processes such as non-conformances, CAPA, and complaint handling, or provide technical input to functions like Order Fulfilment and Manufacturing
• Ensure accurate reporting and documentation across quality assurance processes
• Drive continuous optimisation based on process data and trends
• Participate in audits

Your Profile

• Bachelor's degree in Engineering or a related field
• Several years of relevant experience as a QA Engineer within the medical device industry, with the ability to operate independently
• Strong working knowledge of ISO 13485 and experience in regulated quality environments
• Experience with comparable devices, such as Class IIa or IIb medical devices
• Hands-on audit experience
• FDA experience is a plus, though not required
• Strong written and verbal communication skills
• An open, approachable personality who fits naturally within a relaxed, informal team culture
• Comfortable working efficiently under tight timelines with minimal supervision

Why join?

• Be part of a global organisation making a tangible difference in healthcare
• Step into a close, collaborative Quality and Regulatory team with real ownership from the start
• A permanent role with long-term impact, not a temporary assignment

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

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