Leads the implementation and maintenance of quality systems, ensuring compliance with regulatory standards.
Key Responsibilities:
* Implement, maintain, and improve the Quality Management System (QMS).
* Maintain relationships with suppliers, reviewing and approving new partners in collaboration with purchasing teams.
* Develop quality agreements with suppliers and monitor their performance.
* Support internal and supplier audits as the site Lead Auditor.
* Participate in external audits and contribute to non-conforming items, change controls, and document control.
Requirements:
* Bachelor's degree in Science, Engineering, QA, or a related field.
* Lead Auditor qualification and minimum 2 years' experience in a quality role.
* Solid understanding of regulatory standards: FDA 21 CFR 820, ISO 13485, IVDD 98/79/EC, IVDR (EU) 2017/746.
* Familiarity with ISO 14971 (Risk Management).
What We Offer:
* Competitive salary package.
* 25 days annual leave and health allowance.
* Retail discounts and 24/7 Employee Assistance Programme.
* Ongoing career development & progression opportunities.
We are committed to providing a collaborative environment that fosters growth and innovation. If you are passionate about quality assurance and have a strong background in regulations, we encourage you to apply for this exciting opportunity.