Senior Quality Engineer
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of more than $17 billion, we have approximately 50,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through four premier brands, Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.
Provides expert support to the Quality Manager. This position is responsible for managing the internal NCR process, provides quality support to the validation, supplier approval and supplier complaints processes.
- 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.
- 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.
- Manage the rework process to ensure that any rework is identified and completed in a timely manner.
- 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.
- Manage the supplier complaints process to ensure all supplier issues are recorded, SCAR raised and that supplier corrective actions are reviewed for their effectiveness.
- 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.
- Produce monthly NCR KPI reports.
- Honours degree in a science or engineering subject.
- Fully conversant in Microsoft Word & Excel (especially Pivot tables) and Minitab.
- Six Sigma Green or Black Belt certification preferred.
- Previous experience in blow/injection moulding and extrusion would be 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 would be advantageous
- Full member or Chartered member status of the Chartered Quality Institute would be advantageous.
Non-Negotiable Hiring Criteria:
- Lead QMS auditor qualification.
- Full understanding, via formal training and proven experience in the technical & quality requirements of process validation i.e. IQ/OQ/PQ, including sampling, statistical analysis, protocol and report production and review.
- Formal training and proven experience in the use of quality tools such as RCA, 5Y, 8D, C&E, Pareto, Control Charts etc.