Quality Assurance Engineer II

QUALITY ASSURANCE ENGINEER (MEDICAL DEVICES/PHARMACEUTICALS)
ONSITE / LIVINGSTON - £43-51,000 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 £43-51,000 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