Quality Assurance Compliance Specialist

6 days ago


Liverpool, Liverpool, United Kingdom Pertemps Network Group Full time

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;

  • 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
  • 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.


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