Quality and Compliance Specialist

1 week ago

Peterborough, United Kingdom Specialist Health Solutions Group Full time

**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?**
- Support with the maintenance and continual improvement of ISO 17025, 9001, 14001, 45001, 27001 and GLP management systems
- Perform internal audits and support external audits; document findings and assist in follow-up actions
- Maintain policies, procedures, process maps, and documentation, ensuring accuracy and version control
- Assist in the investigation of non-conformances, near misses, complaints, accidents, and data breaches, supporting robust root cause analysis and corrective actions
- Support the management of CAPA systems, risk registers and compliance schedules
- Collaborate with laboratory staff, management, and external stakeholders to promote compliance awareness and best practice
- Ensure GLP principles are applied in designated studies, support QA inspections and reporting
- 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 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
- Have 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 other 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 completing internal audits and participating external audits for GLP, ISO 17025, ISO 9001, ISO 14001, ISO 45001 and ISO 27001

**What will you get?**
- £30,000 to £38,000 per annum, depending on experience
- Profit Sharing Bonus Scheme
- Commitment to your Personal & Professional Development
- Contributory Pension
- Employee Discounts and Employee Assistance Platform

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