Quality Engineer

Unity Partners; Netherlands; On-site; EUR 46,000 - 70,000; Full time

Job summary

Unity Partners exclusively on behalf of our MedTech partner is seeking an experienced QA Engineer to strengthen the quality team and ensure compliance with medical device standards across the portfolio.

You will collaborate with RA, Engineering, Sales & Marketing, Supply Chain and Manufacturing in a permanent role, operating with minimal supervision and a hands-on approach.

Qualifications

• Bachelor's degree in Engineering or a related field.
• Several years of experience as a QA Engineer in the medical device industry.
• Strong knowledge of ISO 13485 and regulated quality environments.
• Experience with Class IIa/IIb devices is a plus.
• Good written and verbal communication skills.

Responsibilities

• Ensure product quality and compliance for assigned value streams.
• Support the QMS and related regulatory processes locally and globally.
• Represent QA in CAPA, non-conformances, audits, and complaints.
• Ensure accurate reporting and documentation across QA processes.
• Collaborate with Engineering, RA, Supply Chain and Manufacturing.

Skills

QA Engineer experience

ISO 13485 knowledge

FDA experience is a plus

Strong communication skills

Education

Bachelor's degree in Engineering or related field

Job description

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


• 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


• 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


• 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