Supplier Quality Engineer
Reports to: Senior Quality Manager
Our client, a highly respected medical device company are currently looking for a Supplier Quality Engineer to join their team in South Dublin.
The Supplier Quality Engineer will manage all quality related aspects of materials used to make insulin delivery devices, and suppliers of those materials. This covers the management and, as required, the execution of supplier audits, incoming inspections, non-conformance investigations, supplier monitoring and communication. Related duties will include process validation studies, process improvement projects, project management, and application of SPC to production processes.
• Manage all aspects of the Quality System with respect to Supplier quality, including procedures, risk assessments and ASL.
• Liaise with corporate supplier quality on projects, as required.
• Maintain the supplier audit schedule, and execute supplier audits as required.
• Contribution to OCP Supplier Management process, as appropriate.
• Provide support for the ISO9001/2000 and ISO13485 and 21CFR Part 820 Quality Systems.
• Ensure adherence to all company and external regulatory requirements.
• Become an active member of the site internal audit team.
• Prepare and maintain supplier related documentation in compliance with the appropriate regulatory requirements.
• Support projects to identify and qualify new/ alternative suppliers
• Support production personnel in relevant continuous improvement activities (Six Sigma etc.).
• Act as customer liaison contact for key customers as appropriate.
• Review, analyse and report on relevant customer complaints.
• Work with Senior Quality Manager and procurement to develop site strategy with respect to all quality aspects of materials management.
• Ensure line of sight from material specifications, supplier in-process and final release testing, in-coming inspections, sample size and acceptance criteria, to ensure a dependable supply of suitable quality materials to support production.
• Review and Approval of Quality related documents.
• Assist production in development of new or improved material specifications, material systems & processes and co-ordinate with other departments as required.
• Generate documentation appropriate to task (e.g. ECO’s, Material Specification etc.).
• Provide Assistance to interested parties on materials issues as requested by manager.
• Manage the development of new and improved materials, and new suppliers.
• Represent supplier quality at daily production meetings
• Lead response to supplier related QNs in day to day production, driving supplier investigations, responses, etc.
If you would like further Information you can contact the recruiter directly:
Claire Kenny | Tel: +353 (0) 1 507 9287