Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

CooperVision

Gyal, Hungary

RESPONSIBILITIES

  • Supporting the Supplier Quality Management processes for the Hungary Manufacturing facility in accordance with Global Quality Management System (GQMS) requirements;
  • Performing Supplier Qualification evaluation and approval as required;
  • Ensuring that Supplier performance is monitored, reviewed and that Supplier action plans are developed where required;
  • Assess the impact and risk of Supplier changes when notification of changes is received from Suppliers;
  • Investigates raw material Non-Conformances and discrepancies, including raising non-conformance reports and communicating with Suppliers;
  • Lead Supplier audits and maintain the Supplier Audit Schedule for the Hungary Manufacturing facility;
  • Ensuring the Approved Supplier List (ASL) in maintained;
  • Maintaining documentation and files (electronically or paper copy) for approved Suppliers, contractors, and consultants (for example, ISO certificates, quality contracts) for the Hungary Manufacturing facility in Gyál;
  • Participating in the disengagement of Suppliers;
  • Delivers as Subject Matter Expert for the Hungary Manufacturing facility all Supplier Quality related activities and projects;
  • Determining acceptance criteria for parts or materials that may not meet required specifications, including at Supplier sites, as necessary;
  • Promoting Continuous Improvement (CI) with suppliers including regular supplier meetings on site and support with CI projects and identification of corrective actions from non-conformances or audits;
  • Participate for the statistical analyses and weekly and monthly report of the QA indicators;
  • Provides support to all parts of the organization for Supplier Quality, as necessary.

QUALIFICATIONS

  • Bachelor's degree (Chemistry sciences or Engineering is preferred) plus a minimum of 4 years’ experience within a Quality Assurance area, including performing Internal and/or Supplier Audits;
  • Relevant experience in a quality systems/supplier management/medical device/regulatory environment;
  • Lead Auditor trained (ISO 9001 or 13485);
  • Experience and knowledge in a Medical Device Regulated Environment;
  • At least two years working directly in Supplier Quality related activities;
  • Excellent verbal and written command of English;
  • Problem solving and multi-tasking skills;
  • Proactive, good change management skills.

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