Key accountabilities & responsibilities:
- Maintaining good relationships with Supply Chain, Engineering and Manufacturing departments
- Assuring consistent supplier performance & assisting in the development & implementation of supplier management programmes
- Creating or assisting in supplier risk assessments and identifying areas which are critical to quality
- Assess suppliers either remotely or on site. Being a certified Lead Auditor (ISO-13485:2016 preferably)
- Monitoring supplier performance and addressing issues when they arise.
- Either lead or monitor investigations where necessary. Demonstrable experience in root cause analysis is an advantage.
- Facilitating corrective action and preventive actions aimed at addressing supplier quality issues, this includes ensuring appropriate investigations associated with product, supplier performance, and complaints
- Generating, reviewing, and approving of supplier quality-related support documentation
- Reporting supplier performance and quality to management
- Support with maintaining Approved Supplier List
- Experience in facilitating the negotiation process and the completion of quality agreement with suppliers is an advantage
- Reviewing supplier component documentation including 8Ds, dimensional and material reports for sign off acceptance.
- Working with Supply Chain and suppliers to facilitate New Product Introduction to include witnessing production component readiness i.e., Installation Qualification, Operational Qualification and Performance Qualification runs
About you, the candidate:
A natural communicator hopefully goes without saying, but in addition wed like you to have:
- A thorough understanding of Quality Management Systems (the requirements of ISO13485 and FDA 21 CFR part 820)
- Ability to work with suppliers, driving part/s quality improvement projects.
- Experience of Validation process
- Working within the medical device industry
- Practical knowledge & experience in a range of quality techniques, methods and tools, particularly root cause analysis
- A genuine desire to help and support team members so we collectively deliver quality objectives.
- A confident communicator at all levels both within and outside of the organisation.
- Competent with MS Office applications
- A minimum of 5 years previous experience
- Responsibility for oversight of internal audits ensuring timely completion
- Reports to the Quality Manager