Quality Assurance Engineer

grw talent; Livingston; On-site; GBP 43,000 - 51,000; Full time

Job summary

An established industry player in the medical devices sector is seeking a Quality Assurance Engineer II to join their expanding team in Livingston. This role is pivotal in ensuring compliance with ISO 13485 standards and supporting the Quality Management System. You will work closely with various stakeholders, overseeing critical QA processes, conducting audits, and contributing to continuous improvement initiatives. With a competitive salary and benefits package, this is an exciting opportunity for QA professionals looking to make a significant impact in a dynamic environment.

Benefits

Flexible working hours

Generous holidays

Pension contributions

Bonus schemes

Qualifications

• Experience supporting ISO 13485/MHRA audits.
• Generalist QA/QC experience in a manufacturing environment.

Responsibilities

• Oversee Non-Conformance and CAPA processes.
• Support batch review and release activities.
• Conduct process and product audits.

Skills

ISO 13485

Quality Management System (QMS)

Non-Conformance and CAPA processes

Regulatory compliance

Post-market surveillance

Audit processes

Education

Degree in Engineering

Degree in Scientific Discipline

Job description

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 regions including North America. To support this growth, they are hiring a Quality Assurance Engineer II.

This is a site-based role supporting a busy manufacturing facility. Standard hours are 37.5 per week with flexible start/stop times, and any excess hours can be taken as time off in lieu.

Reporting to the Head of Quality Assurance, the Quality Assurance Engineer II will support key elements of the Quality Management System (QMS), batch release, and compliance with applicable standards. This prominent role involves working closely with staff at all levels and participating in internal and external ISO 13485 and MHRA audits. Key responsibilities include:

1. Overseeing Non-Conformance and CAPA processes, working with relevant stakeholders to identify root causes and corrective actions.
2. Updating tracking and trending spreadsheets for monitoring QMS processes.
3. Planning and reporting on post-market surveillance activities.
4. Providing QA review of procedural updates.
5. Supporting batch review and release, including review of batch records, QC testing data, and sterilization records.
6. Reviewing technical and validation protocols and reports.
7. Supporting the Material Review Board with disposition and investigations.
8. Conducting process, product, and workplace audits as part of the internal audit team.
9. Supporting relevant quality KPIs, including trending and reporting of quality metrics.
10. Assisting with notified body audits.
11. Supporting continuous improvement projects, change management, and risk assessments.
12. Contributing to regulatory compliance projects.

Candidates should have a degree in engineering or a scientific discipline and experience supporting ISO 13485/MHRA audits, QA projects, and generalist QA/QC experience. Knowledge of FDA accreditation is advantageous.

This role offers an excellent opportunity for an experienced QA professional to join a large site with expansion plans. The salary ranges from £43,000 to £51,000 and includes bonus schemes, flexible working, generous holidays, and pension contributions.

Applicants must be eligible to live and work in the UK. To apply, send your resume to Bruce Hydes at Grw Talent.