Quality Engineer - Point of Care Diagnostics

Sudbury, Suffolk 12‑Month FTC £23.00-£25.00 per hour 37.5 hours per week | (Mon-Fri, 9am-5pm with flexible start/finish times)

Inspire the Future of Healthcare

Now is our time to shape what comes next - together.

With more than 170 years of innovation, 18,000 patents, and 68,000 colleagues across 70+ countries, our client is a global leader in medical technology. Every day, over 5 million patients worldwide benefit from our diagnostic and therapeutic solutions. We are committed to advancing the future of healthcare through technology, expertise, and collaboration.

We are now seeking a Quality Engineer to join our Point of Care Diagnostics team in Sudbury. This is an exciting opportunity for a dedicated quality professional to support operational excellence and ensure our products consistently meet world‑class regulatory and compliance standards.

The Role

As a Quality Engineer, you will maintain, monitor, and improve the Quality Management System (QMS), supporting operational teams and championing a culture of quality across the site.

Key Responsibilities

Quality Operations

Provide day‑to‑day quality support to Manufacturing Operations Support CAPA and issue resolution to ensure timely, accurate closure Administer deviation and quality notification processes Review, approve, or reject quality‑related documentation Generate quality metrics and reports, and drive KPI‑led improvement initiatives Support change control activities Deliver training on essential QMS elements Participate in SQDIP meetings and ensure delivery of KPIs Use business systems including CATSWEB, CERDAAC, SAP, Documentum, Learn4UAudits & Compliance

Support internal, supplier, regulatory, and customer audits Conduct internal and supplier quality audits Ensure ongoing compliance with: ISO 13485 21 CFR 820 Data Integrity Regulations GAMP standards 21 CFR Part 11EHS & Team Collaboration

Promote a zero‑accident, safety‑first culture Ensure adherence to EHS legislation and company policies Work with project teams on equipment selection, installation, and commissioning

About You

You're proactive, detail‑focused, and passionate about quality.

Skills & Experience

Experience in a medical manufacturing environment advantageous Strong understanding of Quality Management Systems Working knowledge of ISO 13485 and 21 CFR 820 IT proficient, including strong Microsoft Office skills Knowledge of GDP & GMP principles Self‑motivated, reliable, and comfortable working independently Excellent communication and interpersonal skills Flexible, adaptable, and able to manage shifting workloads Curious, engaged, and confident collaborating across functions

Why Join us?

You'll join a global community driven by one purpose: to innovate for healthcare. Here, you'll find a flexible, dynamic environment where you're empowered to grow, take ownership, and contribute to meaningful, life‑changing work.

Join us - and help shape the future of healthcare.

How to apply:

If you are ready to take on this exciting opportunity and become a key player in enhancing customer satisfaction, please submit your application today! We look forward to welcoming a new member to our vibrant team.

Join us in making a positive impact and ensuring our customers' voices are heard!

Note: Due to the high volume of applications we receive, only successful applicants will be contacted. We appreciate your understanding.

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