Senior Quality Assurance Engineer

Description:

Grw Talent is seeking a Senior Quality Assurance Engineer for their client, a global medical devices manufacturer based in Livingston. The company produces controlled eye health care medical devices for customers worldwide and is planning expansion into new geographies, including North America.

This is a site-based role with standard working hours of 37.5 per week, offering flexible start/stop times and the ability to carry over any excess hours. The Senior Quality Assurance Engineer will report to the Head of Quality Assurance and will play a prominent role in managing key elements of the Quality Management System (QMS), Batch Release, and ensuring compliance with applicable standards.

Key responsibilities for the role include:

• Manage QMS processes, including Non-Conformance (NC), CAPA, and Change Control

• Perform Batch Release for all products

• Oversee the Material Review Board and disposition of products

• Be a member of the internal audit team, conducting process, product, and workplace audits

• Report and generate quality KPIs for senior management

• Manage customer complaint handling through to resolution

• Conduct post-market surveillance planning and reporting

• Provide guidance to technical and validation teams

• Support continuous improvement projects, including change management and risk assessments

• Lead regulatory compliance projects, supporting gap analysis and closure actions

• Provide support during notified body audits and subsequent closure

Key Requirements:

• Degree-level education in an engineering or scientific discipline

• Proven experience in medical device, life sciences, or pharmaceutical Quality Assurance

• Strong experience in ISO 13485/MHRA audits, leading QA projects, and mentoring junior colleagues

• Exposure to supplier audits and FDA accreditation knowledge is highly desirable

What We Offer:

• Base salary of £53,000 to £69,000

• Bonus schemes (personal and site-wide)

• Flexible working arrangements

• Generous holiday and pension contributions

• Opportunity to play an integral role in the company’s expansion and lead a growing team