At a Glance
- Tasks: Ensure quality standards in medical devices and support compliance with regulations.
- Company: Innovative medical device company focused on advanced wound care.
- Benefits: Hands-on role with career development opportunities in a supportive team.
- Other info: 100% on-site role in Hertfordshire, ideal for collaborative individuals.
- Why this job: Make a real impact on patient outcomes through quality assurance.
- Qualifications: 2 years of QA experience in the medical device industry required.
The predicted salary is between 35000 - 45000 £ per year.
Cpl Life Sciences are partnering with a growing and innovative medical device organisation specialising in advanced wound care products. The company is committed to improving patient outcomes through safe, effective, and high‑quality medical technologies. The business is seeking a dedicated Quality Assurance Officer to strengthen their Quality team.
As the QA Officer, you will play a key role in maintaining and enhancing the organisation’s Quality Management System (QMS) to ensure full compliance with ISO 13485 and UK medical device regulations. This is an on‑site role based in Hertfordshire, ideal for someone who thrives in a hands‑on, collaborative environment.
You’ll support quality activities across production, design, and supply chain functions, helping the business maintain high standards and continue its impressive growth trajectory.
Key Responsibilities- Maintain and support the ongoing development of the ISO 13485-compliant Quality Management System.
- Review, update, and approve quality documentation including SOPs, CAPAs, deviations, and change controls.
- Support internal audits and contribute to audit readiness for external audits and regulatory inspections.
- Manage document control, ensuring accuracy and compliance across the organisation.
- Assist with product release processes, batch record reviews, and device history documentation.
- Participate in complaint investigations, non-conformance reviews, and root‑cause analysis.
- Collaborate with cross‑functional teams including R&D, Manufacturing, and Regulatory Affairs to ensure quality expectations are met.
- Help drive continuous improvement initiatives across the quality function.
- Essential: At least 2 years’ experience working in Quality Assurance within the medical device industry.
- Strong working knowledge of ISO 13485 and medical device regulatory requirements.
- Experience with CAPA, non‑conformances, document control and QMS processes.
- Excellent attention to detail and strong organisational skills.
- Ability to work 100% on site in Hertfordshire.
- Desirable: Experience working with wound care or similar Class I / II medical devices.
- Exposure to internal auditing or supplier quality activities.
Opportunity to join a small but growing, fast‑moving medical device business with a mission‑driven culture. A hands‑on, impactful QA role where your work directly supports product safety and patient outcomes. Supportive team environment with genuine potential for career development.
Please note this role does not offer job sponsorship and you MUST be able to work in the UK with no restrictions now or in the future.
Quality Assurance Specialist in Luton employer: Cpl Life Sciences
Join a dynamic and innovative medical device organisation in the Watford area, where your contributions as a Quality Assurance Specialist will directly impact patient outcomes through high-quality wound care products. With a mission-driven culture and a supportive team environment, this role offers meaningful work alongside genuine opportunities for career development in a fast-growing company committed to excellence in quality management.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Specialist in Luton
✨Tip Number 1
Network like a pro! Reach out to people in the medical device industry, especially those working in QA. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on ISO 13485 and relevant regulations. Be ready to discuss your experience with CAPA and document control, as these are key areas for the role.
✨Tip Number 3
Showcase your attention to detail during the interview. Bring examples of how you've maintained quality standards in previous roles, and be prepared to discuss specific challenges you’ve faced.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace Quality Assurance Specialist in Luton
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Assurance role. Highlight your experience with ISO 13485 and any relevant QA processes you've worked on. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in the medical device industry. Share specific examples of how you've contributed to quality improvements in your previous roles.
Showcase Your Attention to Detail:As a QA Officer, attention to detail is key. In your application, make sure to demonstrate this skill. Whether it's through your CV formatting or the clarity of your writing, we want to see that you take pride in your work!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen to join our team!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your ISO 13485 Inside Out
Make sure you brush up on your knowledge of ISO 13485 and UK medical device regulations. Be ready to discuss how you've applied these standards in your previous roles, as this will show your potential employer that you're not just familiar with the requirements but can also implement them effectively.
✨Showcase Your Attention to Detail
In a QA role, attention to detail is crucial. Prepare examples from your past experience where your meticulous nature helped prevent issues or improved processes. This will demonstrate your capability to maintain high standards in quality management.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations, like a non-conformance issue or a CAPA process. Think through your past experiences and be ready to explain your thought process and actions clearly. This will highlight your problem-solving skills and practical knowledge.
✨Emphasise Collaboration Skills
Since the role involves working with cross-functional teams, be prepared to discuss how you've successfully collaborated with others in the past. Share specific examples of how you’ve worked with R&D, Manufacturing, or Regulatory Affairs to meet quality expectations, showcasing your teamwork abilities.
