Job Opportunity:
We are seeking a dedicated Quality Systems Specialist to join our team. In this role, you will be responsible for leading and supporting various quality systems activities, including:
• Implementing, maintaining, and improving our Quality Management System (QMS)
• Maintaining relationships with suppliers, distributors, and other economic operators
• Reviewing and approving new suppliers in collaboration with the purchasing and business development teams
• Developing quality agreements with suppliers alongside the purchasing and legal teams
• Monitoring supplier performance and investigating non-conforming materials
• Leading internal and supplier audits as the site lead auditor
• Participating in external audits, such as those conducted by regulatory bodies and customers
• Contributing to non-conformance reports, corrective action plans, change controls, and document control
• Reviewing and approving standard operating procedures, manufacturing documentation, and material control records
• Maintaining strong housekeeping and compliance with health and safety policies
Requirements:
To be successful in this role, you will need:
• A degree in science, engineering, QA, or a related field
• Lead Auditor qualification
• Minimum 2 years' experience in a quality role, preferably in diagnostics or regulated manufacturing
• Solid understanding of regulatory standards, such as FDA 21 CFR 820, ISO 13485, IVDD 98/79/EC, and IVDR (EU) 2017/746
• Familiarity with ISO 14971 (Risk Management)
What's in it for you?
As a member of our team, you can expect:
• 25 days annual leave
• Health allowance and life assurance
• Retail discounts
• 24/7 Employee Assistance Programme
• Recognition & reward schemes
• Ongoing career development & progression opportunities
• A supportive culture driven by our values: Passion | curiosity | integrity | brilliance | respect