Are you looking for a role as a Quality Engineer? We have a fantastic opportunity to join a rapidly growing research and development company on a permanent basis.
Our client is offering an opportunity to be involved in transforming In Vitro Diagnostic testing and providing next generation of healthcare. Due to continued growth of our client's business they are looking for proactive, experienced and enthusiastic individuals who can help make a significant contribution to the continued success of the business.
This role is located at their state of the art facility based in Stirling. There are good transport links and the site is easily accessible from the M9. Stirling is a desirable place to live and work and is easily commutable from Glasgow, Edinburgh or Dundee.
As a Quality Engineer you will be responsible for the development of quality engineering activities associated with IVD sensors (assays) development through the R&D phase and the verification and validation phase.
Key Roles and Responsibilities:
·Quality representative for project teams throughout product lifecycle and product realization activities.
·Creation and management of documentation forming the Design History File and Device Master Record.
·Assess, control and coordinate changes to Design History File and Device Master Record.
·Coach and support in the writing of design requirements and specifications.
·Coach and support in the writing of Verification and Validation plans and protocols.
·Creation and management of traceability matrices.
·Organize, host and facilitate risk management related activities and design reviews with the project teams and ensure compliance of such activities to the applicable standards and regulations.
·Ensure compliance of documentation for design partners (and suppliers) within the supply chain.
·Support clinical processes for assays in development.
·Prepare and create documents and records for upload on to GAS.
·Review and approve as Quality representative on project teams and QMS.
·Review and approve Device History Records and final product release.
·Support the QMS day to day activities, such as CAPA, Change Control, Supplier management, complaints investigation, audits and other routine quality activities.
·Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
·Experience of working in an IVD or medical device environment with a strong quality focus and in-depth experience through development and verification and validation activities.
·Experience of post launch IVD or medical device activities including minimum 2 products.
·Specific experience, degree desired.
·Knowledge and experience in electromechanical medical device Hardware and software projects.
·Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping).
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference TC43073 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Emily Mills
- Phone: 01246 457700
- Reference: TC43073
- Posted: 10th August 2018
- Expires: 7th September 2018