QA Medical Devices jobs
- LonzaSlough SL1 4DX
- Join our Slough team as a Senior QA Specialist providing vital quality oversight for technical services, validation, and data integrity across multi-product…
- Computer FuturesCoventry
- This is a senior role for an experienced QA leader who can combine technical depth with people leadership, taking ownership of the full testing lifecycle across…
- Computer FuturesLiverpool
- We want to see signing/provisioning, simulators/emulators, TestFlight, real-device labs etc named in their experience.
- This contract role sits within our quality assurance function in Leeds, where QA engineers work closely with development, product and operations teams to…
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- Working knowledge of ISO 13485 (medical device quality management) and IEC 62304 (medical device software lifecycle).
View similar jobs with this employerSThreeBirmingham- Domain: Class III medical device · ISO 13485 · IEC 62304.
- Working knowledge of ISO 13485, IEC 62304 and Class III medical device validation.
View similar jobs with this employerSThreeBirmingham- Additional certifications in quality management or medical device compliance.
- Experience with Class III medical device validation, testing or quality assurance.
View similar jobs with this employerSThreeManchester- System Validation Engineer opportunities in medical device development typically sit within quality-focused teams delivering Class III medical devices under ISO…
- Domain: Class III medical device · Validation and quality assurance.
- Involvement in validating medical device systems that support patient safety and clinical…
- Domain: Class III medical device · validation and compliance.
- Demonstrated experience with ISO 13485 and IEC 62304 in a medical device or comparable regulated…
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- Domain: Class III medical device · system validation.
- Professional development in medical device compliance and validation methodologies.
View similar jobs with this employerSThreeManchester- Professional development in regulated medical device environments.
- Domain: Class III medical device · validation and regulatory compliance.
Senior QA Specialist
Job details
Pay
Job type
Full job description
Join our Slough team as a Senior QA Specialist providing vital quality oversight for technical services, validation, and data integrity across multi-product cGMP biotech manufacturing operations on a 6-month contract.
This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.
What you will get:
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An agile career and dynamic working culture.
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An inclusive and ethical workplace.
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Competitive hourly rate.
The hourly rate for this position in the United Kingdom is expected to range between £25.00 and £30.00. Initial salary placement within this range will be determined based on role‑related factors such as experience, qualifications, and expected contribution.
What you will do:
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Provide direct QA review, approval, and oversight for critical GMP quality records, including Deviations, CAPAs, Change Controls, and Investigations.
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Deliver technical QA oversight for validation activities covering facility equipment, clean utilities, and manufacturing processes.
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Support the delivery of the Site Data Integrity (DI) plan while ensuring continuous site audit readiness.
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Escalate and manage major or critical compliance issues through established QMS pathways.
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Act as the Quality Subject Matter Expert (SME) in Local Quality Councils and cross-functional technical project meetings.
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Collaborate closely with Technical Services and Validation teams to drive robust regulatory compliance (MHRA, FDA, EMA).
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Coach and mentor cross-functional colleagues to champion a proactive site-wide cGMP quality culture.
What we are looking for:
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Minimum 5 years of QA experience working within a cGMP biotech or pharmaceutical manufacturing environment.
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Proven technical expertise in QA validation oversight for equipment, utility systems, or manufacturing processes.
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Strong working proficiency with electronic Quality Management Systems (eQMS) such as TrackWise.
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Solid background in Data Integrity governance and deep familiarity with UK/MHRA, EU, and US FDA regulatory standards.
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Strong root-cause analysis skills for investigating complex technical deviations.
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Previous experience in a CDMO environment or leading PQS process improvement projects is advantageous.
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Full availability to work 100% on-site at our Slough facility with valid UK work authorization.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment.
As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.
Ready to play your part in shaping the future of life sciences? Apply now.