Nine Twenty Engineering & Manufacturing are delighted to be continually working with our Stirling based client who are on the look out for an experienced Quality Engineer to handle the Quality Management Systems.
This is a really exciting opportunity to join young company who are continually growing.
Excellent remuneration on offer.
We are looking for someone with preferably a medical device, pharmaceutical or scientific background.
Key Role and Responsibilities
- Coordinate customer complaints
- Coordination of investigations, reporting and feedback to Customer Services
- Manage complaint metrics & trending data
- 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
- Identify and implement improvements in QMS
- Interact with all areas of the organization to ensure that quality processes and procedures are embedded
Essential skills
- Experience of dealing with 3rd parties (eg customers, suppliers, auditors)
- Experience of batch record (or equivalent quality record review)
- Investigation and coordination of customer complaints
- 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
- 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)
Please apply directly via our website if you feel you have the experience for this position.