Type: FTC, occasional travel to the Southern site (expenses provided)
Duration: 12 months (could be extended or potentially lead to a permanent role) Fixed term contract; LTD options may be available.
Salary: Competitive DOE
This position reports into the Manufacturing Quality Manager
Our Client, a Global Medical Devices company are looking to appoint an experienced QE to be involved in a large product and process equipment transfer project.
- Decommissioning coating, slitting and converting production lines, readying processes, records and systems for transfer to an alternative site.
- Developing quality plans for all product families, ensuring accountability of the Quality Plan and Device Master Record through procedural updates and change control
- Ensure thorough and timely investigation of product and process non-conformances and customer complaints through containment action, interim control measures, root cause investigation, providing evidence for product disposition and then ensuring that effective and appropriate corrective and preventative action is implemented and effectivity of CAPAs monitored.
- Develop and use Quality and Process Capability Metrics with Statistical Process Control plans to monitor manufacturing performance and pro-actively identify opportunities.
- Using appropriate six sigma and other QE tools:
- Identify and implement operations and quality system process improvements
- Partner with R&D to support the launch of new products.
- Perform risk analysis, statistical data analysis and develop statistical sample plans for trial, test validation and calibration protocols.
- Partner with Production, Engineering and Operations to ensure effective process validation, change control and process control.
- Provide guidance, leadership and training to QC Analysts as and when required.
- Minimum of 3 years experience within a Quality Engineers role in Medical Devices
- Will have test equipment/ validation/ equipment transfer experience too
- Demonstrated knowledge and application of QSR, MDD, ISO13485, ISO14971 and other international standards.
- Experience of using statistical and other QE tools in a Quality Environment (preferably GB certified or similar)
- Demonstrable knowledge and experience of failure investigation and problem solving methodologies.
- Effective communication skills and the ability and confidence to train personnel.
- Sense of urgency, intellectual curiosity, pro-active mentality, prudent risk-taking, willingness and ability to learn new skills and processes.