Quality Assurance Specialist

Wynne Group; Liverpool; On-site; GBP 40,000 - 50,000; Full time

Job summary

A leading medical device company in Liverpool is seeking a Quality Assurance Officer to ensure compliance with medical regulations and manage Quality Management System (QMS) activities. You will develop training programs, conduct internal audits, and manage CAPA processes. The ideal candidate has a Bachelor's degree, 2-3 years in Quality Assurance, and experience with ISO 13485. This role is critical for ensuring product safety and regulatory compliance.

Qualifications

• Minimum 2-3 years of direct experience in Quality Assurance within the medical device industry.
• Proven working knowledge and application of ISO 13485:2016.
• Qualified Internal QMS Auditor (ISO 13485).
• Direct experience with sterile and non-sterile First Aid and other wound management devices.
• Membership or certification from a professional regulatory body (e.g., RAPS, CQI, ASQ).

Responsibilities

• Maintain, update, and control all QMS documentation in accordance with ISO 13485:2016 requirements.
• Plan and execute internal audits to schedule, identify non-conformities, and track CAPAs.
• Lead the Non-Conformance Report and CAPA processes ensuring thorough investigation.
• Assist in qualifying and auditing suppliers and maintaining the Approved Supplier List.
• Develop and deliver QMS and regulatory training programs for personnel.

Skills

Excellent technical writing

Effective communication

Documentation control

Attention to detail

Proven root cause analysis

Management of CAPA process

Education

Bachelor’s degree in a relevant scientific, engineering, or life science discipline

Tools

Electronic Quality Management Systems (eQMS) software

Job description

Job Description: Quality Assurance Officer

Location: Liverpool, UK. Reporting To: Head of Quality & Regulatory Affairs.

Role Summary

The Quality Affairs Officer is a dual role responsible for ensuring the company's compliance with all applicable UK and international medical device regulations, primarily the UK Medical Devices Regulations (UK MDR) and the EU Medical Device Regulation (MDR, 2017/745). The QA Officer will manage day‑to‑day Quality Management System (QMS) activities and support regulatory compliance and submissions, ensuring our range of products – both sterile and non‑sterile – are safe and compliant for market access.

Key Responsibilities

• 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, identify non‑conformities and track 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.
• Training: Develop and deliver QMS and regulatory training programs for personnel.

Skills, Experience & Qualifications (Essential)

• Education: Bachelor’s degree in a relevant scientific, engineering, or life science discipline.
• Experience: Minimum 2‑3 years of direct experience in Quality Assurance within the medical device industry.
• QMS Knowledge: Proven working knowledge and practical application of the requirements of ISO 13485:2016.
• Auditing Skills: Qualified Internal QMS Auditor (ISO 13485).
• Core Skills: Excellent technical writing, effective communication, documentation control, and attention to detail.
• Problem Solving: Proven ability to perform effective root cause analysis and manage the CAPA process.
• Product Expertise: Direct experience with sterile and non‑sterile First Aid and other wound management devices (class 1 to class IIb).
• Specialized Standards: Practical knowledge of key supporting standards, including ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility).
• System Tools: Familiarity with electronic Quality Management Systems (eQMS) software.
• Professional Body: Membership or certification from a professional regulatory body (e.g., RAPS, CQI, ASQ, TOPRA).