Supplier Quality Engineer is required to provide overall quality management of existing and new supplier products for global medical device manufacturer in County Dublin.
The successful Supplier Quality Engineer will be joining a cross-functional team at our client’s instrumentation manufacturing site in County Dublin. You will be onboarding new suppliers and supporting existing suppliers to deliver high quality parts, conducting supplier audit across our client’s supply base in Europe, reviewing supplier performance and driving continuous improvements with our client’s suppliers through supplier performance reviews.
The manufacturing site is currently involved in new product introductions, so this is an exciting time to join an existing team of Quality professionals to help develop the future processes.
The ideal candidate will have previous experience working within an ISO 13485 and FDA 21 CFR Part 820 regulatory environment.
- Third level degree or higher in Quality Management, Mechatronics, Electronics or Mechanical Engineering or similar discipline with proven experience.
- At least 3 years or more relevant experience in a similar role.
- Strong experience with Mechanical, Mechatronic and Electromechanical measurement systems.
- Highly experienced with auditing to both ISO 9004:2015 and ISO 13485:2016
- Experience with inspection methodologies such as Fabricated/Machined Metal Mechanical/Visual inspection, Precision linear measurement, non-contact measurement, Moulded and Machined plastics inspection and measurement.
- Competent with Geometrical Tolerancing (e.g. true position, perpendicularity, concentricity, angularity, roundness etc.)
- Familiar with Six Sigma, Statistical Analysis and Lean principles for investigations, problem solving and continuous improvement.
- Ability to work in technically complex multi discipline areas across the whole supply chain, including the supplier environment.
- Experience in leading and being a part of teams and projects with strong communications skills.
- Manage our client’s suppliers to deliver quality product to internal customers, through product & process investigations & evaluations.
- Liaise with a wide variety of external suppliers to ensure suppliers are trained and adhere to Quality and Regulatory requirements.
- Develop world-class supply chain processes to suit a low volume, high complexity multi-technology environment (diagnostic instrumentation).
- Build strong value-added ties with our client’s customer base.
- Carry out Supplier Corrective Action Reports and working with suppliers on Root Cause Investigations and Corrective action.
- Conduct Supplier Performance Reviews and Reporting of Key Supplier Quality metrics.
- Support technology transfer initiatives and new projects.
- Support the assessment and selection of new suppliers where applicable.
- Provide daily inspection expertise support to the Purchased Material Inspection Department (PMI) in the areas of Component and Mechatronic.
- Inspect and act as a technical reference to interface with the supplier.
- Contribute to the continuous development of the quality system, including standard operating procedures (SOP’s) coupled with the ability to write concise technical reports.
- Support a Strong Supplier focus to ensure that that our requirements are met appropriately and oversee relevant KPIs for supplier quality oversight.
- Internally support the demands of the instrument and spares supply manufacturing operation.
- Utilise and develop digitalization tools to identify areas for improvement and to streamline quality reports.
- Work with external functional quality and supplier management groups within the company.
Our client offers exciting career growth opportunities as well as benefits such as 25 days AL, Health Insurance, Bonus, Life Assurance, pension, parking, subsided canteen and more.
Please send your CV in confidence to email@example.com