Supplier Quality Engineer

Job Reference: WM1796

Location: Dorset

Salary: £Negotiable (dependent on experience)

Job Type: Permanent

Job Description

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