About Your New Employer
Join a leading medical device manufacturer driven by innovation and a mission to improve patient lives. The company offers a supportive, team-focused culture where your ideas are valued, and your work makes a real difference.
Enjoy excellent work–life balance with a
4-day work week (Monday–Thursday)
and the opportunity to grow your career in a high-performing, collaborative environment.
About Your New Job
As the
Quality Engineer
, you will be a key member of the Quality team, responsible for maintaining and improving the site's Quality Management System. You'll work closely with R&D and Process Engineers to ensure smooth, timely, and cost-effective transitions of products through development, approval, and manufacturing scale-up.
In this role, you will:
* Partner with R&D and Process Engineering teams to support product development, transfers, and process improvements.
* Promote compliance and excellence to meet customer requirements and regulatory standards (FDA, ISO 13485, MDR).
* Lead and execute equipment, process, and product validations in line with quality and regulatory expectations.
* Conduct root cause analysis, manage non-conformances, and implement effective CAPAs to drive continuous improvement.
* Support internal and supplier audits, ensuring findings are addressed and preventive actions are in place.
* Manage and investigate customer complaints, performing failure mode analysis and implementing quality improvements.
* Provide day-to-day Quality support for manufacturing operations, ensuring product and process integrity.
This is a great opportunity for a motivated Quality professional who enjoys problem-solving, collaboration, and making an impact in a regulated, innovative environment.
What Skills You Need
* A
degree in Engineering or Quality Assurance
(or equivalent experience).
* A minimum of
3 years' experience
in a Quality role within a
cleanroom or regulated manufacturing environment
.
* Strong working knowledge of
medical device regulations
(FDA, ISO 13485, MDR).
* Excellent analytical, communication, and interpersonal skills, with the ability to influence cross-functional teams.