Quality Assurance Specialist

Wynne Consulting; Liverpool; On-site; GBP 60,000 - 80,000; Full time

Job summary

A UK-based consulting firm is seeking a Quality Assurance Officer to ensure compliance with medical device regulations in the UK and EU. This role involves managing the Quality Management System, conducting internal audits, and ensuring that documentation meets ISO 13485:2016 standards. The ideal candidate should have proven expertise in QA processes and be eligible to work in the UK, as sponsorship is not provided.

Qualifications

• Must be eligible to work in the UK - Sponsorship not provided.
• Knowledge of UK and EU medical device regulations.
• Experience with Quality Management System documentation.

Responsibilities

• Ensure compliance with UK Medical Devices Regulations and EU MDR.
• Maintain and control QMS documentation as per ISO 13485:2016.
• Plan and execute internal audits to identify non-conformities.

Skills

Documentation Control

Internal Auditing

CAPA Management

Job description

Job Description

Quality Assurance Officer

Must be eligible to work in the UK - Sponsorship not provided.

Location : Liverpool, UK.

Reporting To : Head of Quality & Regulatory Affairs

Role Summary

The Quality Affairs Officer is a crucial 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-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

Quality Management System (QMS) Compliance

• 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 Rep...