Quality Specialist

Job description

QA / RA Specialist

Manchester (Hybrid – 4 days onsite expected)

£42,000 – £50,000 + benefits

Medical Devices | Global Market Exposure

A medical device SME are looking to hire a QA/RA Specialist due to expanding global manufacturing and continued commercial growth.

This role is heavily Quality-focused, with exposure to Regulatory activities, making it ideal for someone looking to broaden their experience across the full product lifecycle.

Why This Role?

• Join a growing global MedTech company expanding manufacturing across Europe, Mexico and Asia
• Work directly alongside the Head of QA/RA in a small, high-impact team
• Gain exposure across supplier qualification, validation, audits and regulatory submissions
• Perfect for someone who enjoys variety and wants to accelerate their development in QA/RA

The Role

You’ll support Quality and Regulatory activities to ensure products meet global compliance requirements across multiple markets.

Key responsibilities include:

• Maintaining and improving the ISO 13485 QMS
• Supporting MDSAP compliance (FDA, Health Canada)
• Supplier quality oversight and qualification activities
• Reviewing and supporting process, software and equipment validation
• Supporting internal and external audits
• Supporting regulatory submissions and product lifecycle compliance
• Maintaining technical documentation including DHF and Technical Files
• Supporting risk management activities aligned with ISO 14971
• Working cross-functionally with manufacturing partners globally

What They’re Looking For:

Essential

• Degree in Engineering, Life Sciences or related discipline
• Experience working within ISO 13485 regulated medical device environments
• Exposure to MDSAP / FDA / Health Canada compliance
• Around 3+ years’ experience in Quality or QA/RA roles

Highly Desirable

• Validation experience (process, software or equipment)
• Internal or external auditing experience
• Risk management exposure (ISO 14971)
• Experience supporting global regulatory submissions

Working Environment

• Hybrid working model (Manchester office being established)
• Collaborative, close-knit international team
• Opportunity to take ownership and broaden responsibilities quickly
• Exposure to global manufacturing and regulatory markets

Interview Process

• Stage 1: Virtual interview with Head of QA/RA
• Stage 2: Virtual interview with senior leadership
• Quick decision process following interviews

If you’re someone who enjoys learning, wants exposure across both QA and Regulatory, and likes working in a growing MedTech environment where you can genuinely influence outcomes — this is a strong opportunity to accelerate your career.

Extra information

Status

Open

Education Level

Secondary School

Location

Manchester Area

Type of Contract

Full-time jobs

Published at

09-02-2026

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English