Senior Quality Assurance Engineer

TN United Kingdom; United Kingdom; On-site; GBP 53,000 - 69,000; Full time

Job summary

An established industry player is seeking a Senior Quality Assurance Engineer to join their expanding team in Livingston. This role offers the chance to manage key elements of the Quality Management System and ensure compliance with ISO 13485 and MHRA standards. You will lead audits, drive quality assurance projects, and mentor junior colleagues in a collaborative environment. With a competitive salary range and extensive benefits, this is an excellent opportunity for those looking to make a significant impact in the medical devices sector while enjoying flexible working arrangements.

Benefits

Flexible working arrangements

Generous holiday

Pension contributions

Personal bonus schemes

Qualifications

• Proven experience in medical device or pharmaceutical Quality Assurance.
• Strong knowledge of ISO 13485 and MHRA standards.

Responsibilities

• Manage QMS processes and perform Batch Release of products.
• Lead internal and external ISO audits and provide quality guidance.

Skills

ISO 13485 Audits

Quality Management System (QMS)

CAPA Management

Batch Release Processes

Regulatory Compliance

Education

Degree in Engineering or Science

Job description

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Senior Quality Assurance Engineer, united kingdom, gb

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Job Reference:

452c9ed7c8e1

Job Views:

2

Posted:

07.05.2025

Expiry Date:

21.06.2025

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Job Description:

SENIOR QUALITY ASSURANCE ENGINEER (MEDICAL DEVICES/PHARMACEUTICALS)
ONSITE / LIVINGSTON - £53-69,000 PER ANNUM PLUS EXTENSIVE BENS

Based in Livingston, Grw Talent’s client is part of a well known global medical devices manufacturer. From their high-volume manufacturing site they make controlled eye health care medical devices and products for customers across the world. Currently employing over 100 people in Scotland, the business continues to grow. Further potential expansion is being planned into new geographies including North America. As part of this expansion plan then now need to make the key hire of a Senior Quality Assurance Engineer.

This is a site based role, supporting a busy manufacturing site, standard hours are 37.5 per week, with flexible start/stop times and any excess weekly hours carried over to be taken in lieu.

Reporting to the Head of Quality Assurance the Senior Quality Assurance Engineer will be responsible for managing key elements of the Quality Management System (QMS), Batch Release and ensuring compliance to applicable standards. This is a prominent role in the business working closely with staff at all levels of the organisation. You will take a prominent role leading / driving internal and external ISO 13485 and MHRA audits. There are a number of key projects led and supported by the quality team that need to be delivered as part of this role. Key responsibilities will include:

• Manage QMS processes, including NC, CAPA and Change control
• Perform Batch Release of all products.
• Oversee the Material Review Board and disposition products
• A member of internal audit team - conducting process, product, and workplace audits
• Responsibility for generating and reporting of quality KPIs to Senior Management
• Manage the Customer Complaint handling through to resolution
• Perform post-market surveillance planning and reporting
• Provide expert guidance and knowledge to technical and validation teams
• Provide quality guidance on continuous improvement projects including change management, and risk assessments
• Lead regulatory compliance projects, supporting gap analysis and action closure to ensure compliance to regulatory standards
• Provide support to management during notified body audits and subsequent closure.

Educated to degree calibre in an engineering or scientific discipline we are looking for proven and highly experienced medical device, life sciences or pharmaceutical Quality Assurance, Senior Quality Assurance, Principal Quality Assurance Engineers or QA Specialists. All candidates should have strong experience leading or closely supporting ISO13485/MHRA audits, driving QA projects across a business and leading / coaching / mentoring junior colleagues in the QA function. Exposure to leading or managing supplier audits and/or a knowledge of FDA accreditation would be a distinct advantage.

This role represents an excellent opportunity for an experienced Quality Assurance specialist who wants to join a large site and geography expansion project. Great opportunity to lead from the front and play an integral role across multiple functions in the business. Your base salary of £53-69,000 is complemented by personal and site wide bonus schemes, flexible working arrangements, generous holiday and pension contributions.

Candidates must be able to live and work freely in the UK.

To apply please send your resume to our recruitment partner Bruce Hydes at Grw Talent.