Quality Release Associate

Quality Release Associate

Location: Cirencester
Department: Quality Assurance

Are you a highly organised administrator with exceptional attention to detail? Do you thrive in a quality-focused environment where accuracy and compliance are critical? We are looking for a Quality Release Associate to join our Quality Assurance team and play a key role in ensuring our medical devices and instrument sets meet the highest standards before release.

As a Quality Release Associate, you will be responsible for reviewing completed batch records (DHRs) and releasing products for stock in accordance with documented work instructions and quality standards. You will work closely with multiple departments to ensure documentation is accurate, complete, and compliant with regulatory requirements.

This is an excellent opportunity for someone with strong administrative skills who enjoys working in a regulated environment and takes pride in delivering high-quality, accurate work.

We have roles on Days 8.30 - 1700 Mon-fri

Double days
- Rotational - this role offers a 20% shift allowance

Earlies Mon-Thur 0515 - 1345 then Fri 0515
-1045

Lates Mon
- Thur 1400 - 2230 then Fri 1100 - 1630

• Review completed batch records (DHRs) and release products for stock in accordance with approved work instructions and checklists.
• Liaise with internal departments to resolve documentation queries and clarify any issues identified during DHR reviews.
• Publish regular updates regarding batch review and release activities.
• Perform transactional activities within relevant business systems, including Sage and IQM, supporting batch disposition and non-conformance reporting.
• Maintain quality records to ensure secure storage and efficient retrieval, including coordination of off-site records.
• Provide support to colleagues involved in batch release and associated documentation activities.
• Support Quality Assurance and cross-functional projects as required.
• Undertake general administrative duties to support departmental objectives.
• Provide documentation support during internal, customer, regulatory and notified body audits.
• Ensure compliance with the Quality Management System (QMS), ISO 13485 requirements, Good Manufacturing Practice (GMP) standards and FDA 21 CFR Part 820 regulations.
• Support Corrective and Preventive Action (CAPA) activities, ensuring timelines and process requirements are met in line with company procedures.

The ideal candidate will have:

• Previous experience working within a quality-driven environment, ideally within the medical device, pharmaceutical, healthcare or other regulated industry.
• Strong administrative skills with a high level of proficiency in Microsoft Excel and Word.
• Excellent attention to detail and a commitment to accuracy.
• The ability to work effectively under pressure and manage multiple priorities.
• Strong organisational skills with a consistent and methodical approach to work.
• Excellent communication skills and the confidence to work with stakeholders across different departments.
• A proactive attitude and willingness to support continuous improvement initiatives.

This is an opportunity to contribute directly to the quality and compliance of products that improve patients' lives. You'll join a collaborative team environment where your attention to detail and commitment to quality will make a real difference.

• A competitive salary £24,900-£29,000 and a discretionary annual bonus
• 25 days holiday plus bank holidays
• Excellent pension - starts at 6%, going up to 9.7% after 18 months.
• Life assurance
  - Six times your basic salary
• Private medical insurance with BUPA for you and your family
• Free annual eye tests and flu vaccinations
• Employee referral program where you can earn from £1,000 for each successful hire you recommend