Nine Twenty Engineering & Manufacturing are delighted to be representing our Stirling-based Manufacturing client in their search for a number of Quality Engineer to join the team on a Permanent basis.
This opportunity presents the chance for an upbeat and proactive individual to join a dynamic company to make a real contribution to the continuing growth and success of the organisation as well as putting a strong emphasis on personal development.
Excellent remuneration on offer.
We are looking for someone with preferably a medical device, pharmaceutical or scientific background.
Key Role and Responsibilities
- Batch record review and product release
- Device Master Record updates
- Review of non conformances, planned deviations and change controls
- Prepare and create documents and records for upload on to documentation management system
- Internal auditor
- Identify and implement improvements in LumiraDx QMS
- Interact with all areas of the organization to ensure that quality processes and procedures are embedded
Essential skills
- Experience of batch record (or equivalent quality record) review
- Experience of coordination and QA review of non-conformances and planned deviations
- Experience of working with quality systems and processes (eg audit, non-conformance, CAPA, change control)
- Knowledge and experience of working to the quality and regulatory standards in a medical device, pharmaceutical or similar manufacturing industry with a proven track record in a relevant role
- Experience of working in a dynamic fast-paced environment
- Ability to use problem-solving tools and methodologies
- Influence internal team and external parties to maximize success opportunities
Desirable skills
- Knowledge and experience of working in a quality assurance role in medical devices and of the quality and regulatory standards ISO13485, FDA 21CFR Part 820.
- Trained auditor
- Knowledge and experience in immunoassays and molecular assays
- Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)