Job Description
Your Key Responsibilities
* Support design control processes to ensure compliance with industry regulations.
* Act as the quality representative in projects, providing expert guidance from start to finish.
* Manage change control processes by collaborating across departments like R&D, Operations, and Labelling.
* Lead risk management activities, including creating and maintaining Risk Management Files.
* Facilitate failure mode and effects analysis (FMEA) meetings and other critical quality initiatives.
* Provide training to team members on design and change control requirements.
* Perform post-market surveillance and internal audits to maintain top-tier compliance.
Qualifications
We're Looking for Someone with:
* A BSc in Science, Engineering, or Quality Assurance, plus at least 2 years of experience in a quality function.
* Knowledge of risk management practices-experience in the IVD or medical device industry is a bonus.
* Familiarity with standards like FDA 21CFR820, ISO13485, and IVDR EU/2017/746.
* Exceptional communication and interpersonal skills to collaborate across teams.
* Strong problem-solving skills and meticulous attention to detail.
Why Join Us?
About Our Company
You'll be part of a collaborative, supportive environment where your ideas matter. You'll have opportunities to work on impactful projects in the healthcare sector and grow professionally while making a tangible difference in people's lives.