Career vacancy: Quality Assurance Specialist

We are looking for Quality Assurance Specialists to join our team within our Medical Device testing laboratory at Peterborough.

Do you have what it takes to be one of the Test Labs team?

We are looking for people who challenge themselves, to set goals, and go above and beyond what is required of them in their role, to achieve these.

Our people passionately strive for excellence which you will see in their careful attention to detail. We are inquisitive and we like to understand, not just for the sake of more knowledge but to fuel our innovation in delivering best services, and solutions for our customers. We call this resourcefulness, and a sense that perfection is only just good enough.

We believe that for you to enjoy success in your work, you must apply energy and focus to the tasks you have to do every day. We like to give you the opportunity to stretch yourself beyond your natural ‘comfort zone’ in the knowledge that you will be guided by your inner principles to do the right thing by the business, your colleagues and our customers.

These core values are at the heart of what we do and are easier to feel than to talk about. Show us these and we will enjoy having you on the team at Test Labs!

What do we do?

Test Labs is GLP Certified, ISO17025 Accredited Medical Device Testing Laboratory. We specialise in medical device testing and validation, focusing particularly on instructions for use validation and material compatibility studies to ensure compliance with global regulations.

We’re driven by the knowledge that what we do goes far beyond mere compliance; it’s about ensuring the highest standards of quality, safety, and reliability of medical devices. ‘Beyond Market Access’ is our commitment to patient-focused care, not just market readiness. We believe our approach and results set us apart from the rest.

We are relentless in our pursuit of excellence. We hunger for knowledge, challenges, and the constant evolution of healthcare solutions, which drives us to push boundaries, fostering a dynamic, innovative environment. Grounded in humility, we recognise the collective strength of our diverse team. We acknowledge that collaboration fuels innovation. Our humility allows us to learn from each other, embrace feedback, and continuously grow, fostering a culture of mutual respect and open communication.

Intelligence is not just about technical prowess; it’s about emotional intelligence, effective collaboration, and strategic thinking. Together, these values create a culture where ambition meets collaboration, where passion meets practicality, and where innovation meets impact. People who live our values, thrive at Test Labs and benefit both personally and professionally by engaging in the Test Labs journey.

What are we looking for in this position?

As a Quality Assurance Specialist at Test Labs, you will uphold the quality and integrity of our medical device testing. You will plan, conduct and report on GLP and study-specific audits, maintain and improve our management systems, and work closely with laboratory teams to identify risks, resolve issues and drive improvements. You will also guide colleagues across the business on quality, health and safety, environmental and information security matters.

What will you do?

• Always uphold our company core values; Hungry, Humble, Smart
• Establish, maintain, and review management system policies, procedures, process maps and documentation, ensuring they are kept accurate and up to date
• To maintain an effective audit schedule and perform internal audits to meet the requirements of all management systems, including facility, process based and study specific audits and produce detailed reports outlining the findings agreed
• Assist and liaise with management in the investigation of near misses, complaints, accidents, incidents and security breaches and notify all relevant internal and external interested parties
• Assist with managing all the internal and external non-conformances and opportunities for improvements, ensuring a robust root cause analysis is carried out, ensure actions are followed up, implemented, and monitor effectiveness of actions taken
• To liaise with external certification bodies and external auditors and participating in external audits
• Assisting in the maintenance and improvements of the quality, occupational health and safety, environmental and information security management systems based on objectives and strategy set by the company
• Maintenance of the standards/publications relating to the laboratory, legal compliance and aspects and impacts register, keeping them up to date with changes in quality, health and safety, environmental and information security legislation/requirements
• Support with identification of risks and follow up on agreed mitigating measures ensuring these are documented within the risk registers and that appropriate risk assessments performed and are in place
• Schedule, prepare for and attend compliance meetings, documenting outcomes and any actions raised
• Support with management of contractors/suppliers and facility servicing and maintenance records to ensure compliance
• To support and effectively communicate with the sales, operations and other functions within the business to provide support for management and employees on matters relating to health, safety, environmental and information security
• Take part in training and development to meet organisational standards/needs and support with the maintenance of a training management system for employees within the business
• Ensure the principles of Good Laboratory Practice Regulations are complied with for designated studies and act as quality assurance personnel including:
  • Maintaining a copy of all approved study plans and standard operating procedures in use in the test facility and have access to an up-to-date copy of the master schedule
  • Verify that the study plan contains the information required for compliance against regulations and keeping records of verification
  • Conduct study based, facility based or process-based inspections to determine if all studies are conducted in accordance with the principles of good laboratory practice (including determining that study plans and SOPs have been made available to study personnel and are being followed)
  • Inspect final report to confirm that methods, procedures and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the regulatory study
  • Promptly report any inspection results in writing to management and to the study director, and to any principal investigator and the respective management, when applicable
  • Prepare and sign a statement, to be included with the final report, which specifies the types of inspections and their dates, including the phase of a study inspected, and the dates inspection results were reported to management and the study director and any principal investigators, if applicable. This statement would also serve to confirm that the final report reflects the raw data.
• Act in accordance with compliance and statutory obligations listed with legal compliance registers including GDPR and the Data Protection Act
• Adherence to the company Management Systems and external certifications/accreditations maintained – including responsibilities outlined in the company policies and procedures such as the “Overview and context of the organisation”.

What will you need to have?

• Experience in a dedicated quality assurance role within a GLP-compliant, UKAS-accredited testing laboratory.
• A background in medical device testing, with a strong understanding of the quality requirements governing laboratory work and regulatory studies.
• Hands-on experience independently planning, conducting and reporting on GLP study-specific, facility and process-based audits.
• Experience reviewing study plans, checking final reports against raw data and preparing GLP quality assurance statements.
• A thorough understanding of GLP and ISO/IEC 17025 requirements, including data integrity, traceability and the independence of the quality assurance function.
• Experience preparing for and participating in MHRA inspections, UKAS assessments and external certification audits, including responding to findings.
• A proven ability to investigate non-conformances, establish root causes and follow corrective actions through to verified completion.
• Experience maintaining and improving laboratory management systems, supported by working knowledge of ISO 9001, ISO 14001, ISO 45001 and ISO 27001.
• Sound judgement and the confidence to challenge decisions, escalate concerns and uphold standards under pressure.
• Clear communication skills, with the ability to explain requirements, provide constructive feedback and help colleagues put improvements into practice.
• A methodical approach, close attention to detail and the ability to manage competing compliance priorities independently.

What will you get?

• A competitive salary
• 25 days holiday + bank holidays
• Hybrid working model
• Profit Sharing Bonus Scheme
• Commitment to your Personal & Professional Development
• Contributory Pension
• Employee Discounts and Employee Assistance Platform

Most of all you will be a part of the Test Labs Family, who are a team of motivated and inspiring individuals wanting to play their part in changing the industry and making a difference. Test Labs is an equal opportunity employer that is committed to diversity and inclusion in the workplace.

Ready to apply?

Does this role sound like you? Are you the driven, resourceful type who goes above and beyond to get results? Then apply today!