An organization in the medical sector, an established player in the medical device industry, develops 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 are at the core of how they operate. To strengthen their Quality team, they are looking for an experienced QA Engineer who can hit the ground running and make a direct impact from day one.
You will 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.
What you will do.
- Ensure product compliance for an assigned value stream within the product portfolio
- Support the local and global QMS and related processes
- Non-conformances, CAPA, and complaint handling
- Internal and external audits
Profile
- Bachelor's degree or higher in Engineering or a related field
- 5+ years of relevant experience as a QA Engineer within the medical device industry, with the ability to operate independently from day one
- 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
- Strong written and verbal communication skills
- Comfortable working efficiently under tight timelines
Practical
- A focused interim assignment with immediate impact within a global medical technology organization
- Step into a close, collaborative Quality and Regulatory team with real ownership from the start
- Competitive day rate in line with experience
How to apply
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