Quality Assurance Engineer II

GRW Talent limited; Scotland; On-site; GBP 43,000 - 51,000; Full time

Job summary

An established industry player in medical devices is seeking a Quality Assurance Engineer to support their expanding operations in Livingston. This onsite role offers a competitive salary and the chance to work on critical quality management projects, including ISO 13485 audits and compliance initiatives. You'll collaborate with diverse teams, ensuring the highest standards in product quality and safety. This is a fantastic opportunity for a dedicated professional eager to make a significant impact in a growing organization that values innovation and quality. Join a team that is committed to excellence and be part of an exciting journey in the medical sector.

Benefits

Flexible working arrangements

Generous holiday

Pension contributions

Personal bonus schemes

Qualifications

• Experience in medical device or pharmaceutical QA.
• Knowledge of FDA accreditation is advantageous.

Responsibilities

• Oversee Non-Conformance and CAPA processes.
• Conduct internal audits and support regulatory compliance projects.
• Provide QA support on continuous improvement projects.

Skills

ISO 13485

Quality Assurance

CAPA processes

Post-market surveillance

Regulatory compliance

Quality Metrics

Education

Degree in Engineering or Scientific Discipline

Tools

Quality Management System (QMS)

Tracking and Trending Spreadsheets

Job description

QUALITY ASSURANCE ENGINEER (MEDICAL DEVICES/PHARMACEUTICALS)
ONSITE / LIVINGSTON - GBP43-51,000 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 Quality Assurance Engineer II.

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 Quality Assurance Engineer II will be responsible for supporting 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 across internal and external ISO 13485 and MHRA audits. There are a number of key projects led and supported by the broader quality team that need to be delivered as part of this role. Key responsibilities will include:

• Oversee the Non-Conformance and CAPA processes, working with relevant stakeholders to determine root cause and actions required
• Update tracking and trending spreadsheets for monitoring of QMS processes
• Perform post-market surveillance planning and reporting
• Provide QA review of procedural updates
• Support batch review and release inc. review of batch records, QC testing data and sterilisation records
• Review of technical and validation protocols and reports
• Support the Material Review Board on disposition and investigations
• A member of internal audit team - conducting process, product, and workplace audits
• Support relevant quality KPIs including trending and reporting of Quality Metrics
• Support notified body audits
• Provide QA support on continuous improvement projects including change management, and risk assessments
• Support regulatory compliance projects

Educated to degree calibre in an engineering or scientific discipline we are looking for an experienced medical device, life sciences or pharmaceutical Quality Assurance Engineer or Quality Assurance Specialist. Candidates should have some experience supporting ISO13485/MHRA audits, contributing to QA projects across a business and possess good generalist QA and some QC experience. Exposure or knowledge of FDA accreditation would be a distinct advantage.

This role represents an excellent opportunity for an experienced Quality Assurance professional who wants to join a large site and geography expansion project. Great opportunity to play an integral role across multiple functions in the business. Your base salary of GBP43-51,000 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.