Senior Supplier Quality Engineer
Our client, one of the largest multinational company based in UK is recruiting for Senior Supplier Quality Engineer. The role is responsible for the coordination and implementa-tion of on-site and documentation audits, related observations, NCs, CAPAs and communication of evaluation results to key stakeholders. Provide cross-functional supplier au-diting services to R&D, Acquisition, Manufacturing, Materials, Purchasing, and Opera-tions stakeholders worldwide.
• Drive continuous improvement within the Stryker supply base, ensure compli-ance and conformance, and ensure effective and efficient Quality Management Systems are established, documented, implemented, and maintained.
• Complete risk-based audits of suppliers per companies required cycle times to ensure conformance and compliance.
• Provide compliant records for FDA, ISO, Corporate, Internal, 2nd party, and Opera-tions audits.
• Ensure supplier Quality Management Systems comply with applicable FDA and ISO regulations and requirements.
• Identify and write findings and observations during evaluations and drive timely clo-sure of NCs through the CAPA system.
• Evaluate processes, write audit reports, write non-conformances, and store records per Document Control requirements.
• Ensure a timely supply of conforming components and products to company through process sustainment.
• Root cause analysis of processes related manufacturing defects and warranty con-cerns.
• Communicate results of supplier evaluations to companies stakeholders and suppli-ers to ensure adequate responsiveness
• Foster strong relationships with companies supplier-partners acting as an extended enterprise
• Complete on-site audits of suppliers’ Quality Management Systems through risk based processes audits
• Bachelor of Science in engineering, or engineering related discipline required
• 3-5 years of relevant experience in Quality, Management, or Engineering
• Experience in medical device industry preferred
• Experience working onsite developing suppliers preferred
• Knowledge of Quality Management Systems, FDA 21 CFR Part 820, ISO13485 and/or ISO9001 required
• ASQ or RABQSA certification preferred (i.e. CQE, CQA, Lead Auditor)
• ISO-13485 Lead Auditor certification or equivalent preferred
• Experience conducting supplier audits and internal audits preferred
• Demonstrated collaboration, negotiation, and conflict resolution skills
If you would like further Information you can contact the recruiter directly:
Jannet Diana | Tel: +353 (0) 1 507 9255