Quality Assurance 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

Continuous optimisation

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