Are you detail‑driven, proactive, and passionate about maintaining high-quality standards? We’re looking for a Quality Assurance Associate to join an exciting medical device organisation and play a key role in supporting our Quality Management System and ensuring compliance with regulatory and industry standards.
About the Role
As a Quality Assurance Associate, you will help maintain and continuously improve the Quality Management System, ensuring products, processes, and documentation meet required regulatory and quality expectations. This is a fantastic opportunity for someone who thrives in a structured environment and enjoys working cross‑functionally to uphold excellence.
Key Responsibilities
* Support the maintenance and ongoing improvement of the Quality Management System in line with relevant regulations and standards (e.g., ISO 13485).
* Assist with developing, reviewing, and updating quality manuals, SOPs, and related documentation.
* Review and receipt Goods Received Notes (GRNs) for inbound containers, ensuring accuracy against supplier and shipment documentation.
* Evaluate pre‑production samples to verify compliance with approved specifications before full production.
* Support preparation for and participation in notified body audits .
* Monitor regulatory updates and help implement required changes.
* Liaise with suppliers and support supplier audits, including preparing approved supplier submissions.
* Assist with Corrective and Preventive Actions (CAPA) .
* Manage and monitor product complaints .
* Support maintenance of MHRA registration .
* Review product labelling, packaging, and artwork for regulatory and procedural compliance.
* Maintain version control and ensure latest approved artwork/labels are used in production.
* Assist with change control activities related to product and process updates.
* Support employee training on quality procedures and requirements.
What We’re Looking For
* Strong attention to detail and organisational skills
* Ability to work independently and collaboratively
* Familiarity with quality standards (ISO 13485 preferred)
* Effective communication skills
* Previous experience in quality, regulatory, or a related field is a plus
Please note this role does not offer job sponsorship, and you must be able to work in the UK with no restrictions.
For more information please get in touch - jamie.keith@cpl.com