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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;
- Documentation Control: Maintain, update, and control all QMS documentation in accordance with ISO 13485:2016 requirements.
- Internal Auditing: Plan and execute internal audits to schedule, identifying non-conformities and tracking Corrective and Preventive Actions (CAPAs).
- CAPA & NCR Management: Lead the Non-Conformance Report (NCR) and CAPA processes, ensuring thorough investigation, root cause analysis, and effective closure.
- Supplier Management: Assist in qualifying and auditing suppliers, maintaining the Approved Supplier List, and ensuring supplier quality agreements are in place.
- 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).
- UKCA & CE Marking: Support the generation of Declaration of Conformity (DoC) documents for product placement in the UK (UKCA) and EU (CE) markets.
- 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;
- Must have a Bachelor's degree in a relevant scientific, engineering, or life science discipline.
- Minimum 2-3 years of direct experience in Quality Assurance or Regulatory Affairs within the medical device industry.
- Proven working knowledge and practical application of the requirements of ISO 13485:2016.
- Demonstrable understanding of the UK Medical Devices Regulations and the EU MDR (2017/745).
- Qualified Internal QMS Auditor (ISO 13485).
- Excellent technical writing, effective communication, documentation control, and attention to detail.
- Proven ability to perform effective root cause analysis.
- Familiarity with electronic Quality Management Systems (eQMS) software.
