* QA Officer – Medical Devices (Wound Care)
* Full-Time, Permanent role
Minimum 2 Years’ QA Experience is Required
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.
About You
* 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.
* Experience working with wound care or similar Class I / II medical devices.
* Exposure to internal auditing or supplier quality activities.
What’s on Offer
* 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.
For more information, please contact lucy.kirkaldy@cpl.com
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