- Experience Level
- Experienced (non-manager)
- Responsible for the management of the internal NCR process.
- Ensure that effective root cause analysis has been carried out and that corrective action plans are produced, are effective and completed within the agreed timescales.
Global Life Science Organisation specialise in production and development of IVD devices for DNA,RNA and laboratory testing.
- Responsible for the management of the internal NCR process. Ensure that effective root cause analysis has been carried out and that corrective action plans are produced, are effective and completed within the agreed timescales.
- Train relevant personnel in root cause analysis as required.
- Analyse NCR data and monitor trends to highlight further areas of improvement.
- Produce monthly NCR KPI reports.
- Work closely with the engineering team to ensure all validations are carried out to the required standard.
- Review all validation protocols and reports to ensure suitability.
- Produce and maintain the Master Validation Plan for all products.
- Collaborate with the purchasing team to ensure new suppliers are reviewed and approved.
- Carry out supplier audits as required.
- Ensure specifications, drawings, technical data sheets in place and maintained for all raw materials and components.
- Carry out internal audits as per the internal audit schedule.
- Degree in a science or engineering subject.
- Fully conversant in Microsoft Word & Excel (especially Pivot tables) and Minitab.
- Previous experience in blow/injection moulding and extrusion (advantageous).
- Formal qualifications in quality e.g. CQI Diploma, A11, A12 or MSc (preferred).
- Previous experience in a quality role in the medical device, IVD or pharmaceutical sectors.
Competitive Salary, Relocation Package and the opportunity to work for a market leading brand