Job Title: Quality & Compliance Officer
Location: Liverpool (L24)
Salary: £34,000 - £39,000 (DOE) + Benefits
Shifts: Monday- Friday 08:45 - 17:00hrs (100% office based)
Job Type: Permanent
Our client is a well-established market leader in supply of medical products and services to UK workforces, which include a variety of high-profile businesses.
We are currently recruiting for an experienced Quality & Compliance Officer to work out of their Liverpool office to manage the day-to-day QMS activities to ensure products are safe and compliant for market.
As the Quality & Compliance Officer, your duties will be;
1. Documentation Control: Maintain, update, and control all QMS documentation in accordance with ISO 13485:2016 requirements.
2. Internal Auditing: Plan and execute internal audits to schedule, identifying non-conformities and tracking Corrective and Preventive Actions (CAPAs).
3. CAPA & NCR Management: Lead the Non-Conformance Report (NCR) and CAPA processes, ensuring thorough investigation, root cause analysis, and effective closure.
4. Supplier Management: Assist in qualifying and auditing suppliers, maintaining the Approved Supplier List, and ensuring supplier quality agreements are in place.
5. Technical Documentation: Prepare, compile, and maintain essential elements of the Technical File (TF) and Design Dossiers, focusing on clinical data, risk management (ISO 14971), and post-market surveillance (PMS).
6. UKCA & CE Marking: Support the generation of Declaration of Conformity (DoC) documents for product placement in the UK (UKCA) and EU (CE) markets.
7. Post-Market Surveillance: Manage the PMS system, including review of post-market clinical follow-up (PMCF) activities, processing customer complaints, and assisting with adverse event reporting (Vigilance) to competent authorities.
The successful Quality & Compliance Officer have the following skills;
8. Must have a Bachelor's degree in a relevant scientific, engineering, or life science discipline.
9. Minimum 2-3 years of direct experience in Quality Assurance or Regulatory Affairs within the medical device industry.
10. Proven working knowledge and practical application of the requirements of ISO 13485:2016.
11. Demonstrable understanding of the UK Medical Devices Regulations and the EU MDR (2017/745).
12. Qualified Internal QMS Auditor (ISO 13485).
13. Excellent technical writing, effective communication, documentation control, and attention to detail.
14. Proven ability to perform effective root cause analysis.
15. Familiarity with electronic Quality Management Systems (eQMS) software.