Quality and Compliance Lead

Who are Test Labs?

Test Labs cut through the complexity of medical device testing, their set up allows them to offer highly tailored solutions globally, ensuring strict compliance with EU CE Mark, UKCA Mark, FDA, Health Canada and SFDA requirements. Our core values: Hungry, Humble, Smart serve as the core foundations of our organisational culture, driving us toward unprecedented achievements in Healthcare Innovation, enabling us to deliver Better Healthcare, Faster.

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?

• Establish, maintain, and review management system policies, procedures, process maps and documentation, ensuring they are kept accurate and up to date.
• 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.
• Assist and liaise with management in the investigation of near misses, complaints, accidents, incidents and information security breaches and notify all relevant internal and external interested parties.
• Manage all internal and external non-conformances and opportunities for improvements, ensuring robust root cause analysis is carried out, actions are followed up, implemented, and monitor effectiveness.
• Liaise with external certification bodies and external auditors and participate in external audits.
• Assist 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.
• Maintain 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 are performed and 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.
• Communicate effectively with 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.
• Participate 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.
• Act in accordance with compliance and statutory obligations listed with legal compliance registers including GDPR and the Data Protection Act.
• Adhere to the company Management Systems and external certifications/accreditations maintained - including responsibilities outlined in the company policies and procedures.

What will we need you to have?

• Always represent our Core Values: Hungry, Humble, Smart.
• Ability to maintain a high level of attention to detail and a methodical approach.
• Excellent verbal and written communication skills.
• Excellent IT skills (Word, PowerPoint, Excel, Outlook, MS Planner).
• Ability to work in, and adapt to, a rapidly changing environment.
• Ability to work cooperatively with others to complete tasks and implement process improvement.
• Ability to prioritise and manage workload within a fast-paced environment.
• The ability to troubleshoot problems and develop solutions.
• Experience working in a GLP and UKAS accredited laboratory.
• Experience in the medical device industry.
• Experience completing internal audits and participating in external audits for GLP, ISO 17025, ISO 9001, ISO 14001, ISO 45001 and ISO 27001.

What will you get?

• 1 Year Fixed Term Contract.
• £40,000 to £50,000 per annum, depending on experience.
• Profit Sharing Bonus Scheme.
• Commitment to your Personal & Professional Development.
• Contributory Pension.
• Employee Discounts and Employee Assistance Platform.