Senior Quality Assurance Engineer

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