Our ideal candidate is a seasoned professional in quality assurance engineering with extensive experience in medical device sectors. The role offers an exciting opportunity to join a dynamic team as they expand their European operations at a cutting-edge manufacturing site.
This onsite position plays a critical role in ensuring the quality and precision of components supporting life-enhancing technologies. It involves working at the forefront of innovation, collaborating cross-functionally with R&D, Supplier Quality, and Operations Engineering to drive robust inspection processes.
The responsibilities include:
* Lead the evaluation and implementation of inspection methods and sampling plans for high-volume and complex components
* Collaborate with R&D, Supplier Quality, and Operations Engineering to develop and implement effective inspection processes
* Design, develop, and qualify custom inspection fixtures and measurement equipment
* Conduct Gage R&R studies and measurement system analyses to ensure repeatability and accuracy
* Develop and validate test methods in compliance with industry standards and regulatory requirements
* Investigate and resolve Out-of-Spec (OOS) events and drive root cause analysis and CAPA activities
To be successful in this role, you should possess:
* Bachelor's or Master's degree in Engineering or a related technical discipline
* 5+ years of quality engineering experience within the medical device, biotech, or pharmaceutical sectors
* Strong experience in inspection methods, fixture design, and measurement systems analysis (including Gage R&R)
* Proficient in CAD software (e.g., SolidWorks) and statistical analysis tools (e.g., Minitab)
* Working knowledge of GD&T, mechanical drawings, and regulatory frameworks including ISO 13485 & FDA 21 CFR Part 820
We are looking for someone with a proactive mindset, strong problem-solving skills, and a passion for improving human health through high-quality engineering solutions.