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SENIOR QUALITY ASSURANCE ENGINEER (MEDICAL DEVICES/PHARMACEUTICALS)
Based in Livingston, Grw Talent’s client is part of a well known global medical devices manufacturer. From their high-volume manufacturing site, they produce controlled eye health care medical devices and products for customers worldwide. Currently employing over 100 people in Scotland, the business continues to grow, with expansion plans into new geographies including North America. As part of this growth, they now seek a Senior Quality Assurance Engineer.
This is a site-based role supporting a busy manufacturing facility. Standard hours are 37.5 per week, with flexible start/stop times. Any excess hours can be taken as time off in lieu.
Reporting to the Head of Quality Assurance, the Senior Quality Assurance Engineer will manage key aspects of the Quality Management System (QMS), oversee Batch Release, and ensure compliance with applicable standards. This role involves working closely with staff at all levels and leading/internal/external ISO 13485 and MHRA audits. Key projects led or supported by the quality team will also be part of this role. Responsibilities include:
1. Manage QMS processes, including NC, CAPA, and Change Control
2. Perform Batch Release of all products
3. Oversee the Material Review Board and product disposition
4. Conduct process, product, and workplace audits as part of the internal audit team
5. Generate and report quality KPIs to Senior Management
6. Manage customer complaint handling from initiation to resolution
7. Perform post-market surveillance planning and reporting
8. Provide guidance to technical and validation teams
9. Support continuous improvement projects, including change management and risk assessments
10. Lead regulatory compliance projects, supporting gap analysis and action closure
11. Assist during notified body audits and ensure closure of findings
Candidates should have a degree in engineering or a scientific discipline and proven experience in medical device, life sciences, or pharmaceutical QA roles. Experience leading or supporting ISO 13485/MHRA audits, managing QA projects, and mentoring junior staff is essential. Knowledge of FDA accreditation and supplier audits is advantageous.
This role offers an excellent opportunity for an experienced QA professional to play a key role in a growing company. The salary ranges from £53,000 to £69,000, complemented by bonuses, flexible working, generous holidays, and pension contributions.
Candidates must be eligible to live and work in the UK.
To apply, send your resume to Bruce Hydes at Grw Talent.
Seniorities and employment details
* Mid-Senior level
* Full-time
Job functions and industries
* Quality Assurance, Production, and Science
* Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Biotechnology Research
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