QA & Compliance Officer – Medical Devices (ISO 13485)

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

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.