Senior Supplier Quality Engineer

1 month ago

Glostrup, Glostrup Kommune, Denmark Agilent Full time
Job Summary

Agilent is seeking a Senior Supplier Quality Engineer to ensure compliance with various Regulations and Standards, lead Supplier Quality Compliance Projects, develop Partner Quality Agreements, manage high visibility SCARs, and conduct key Supplier Audits.

Key Responsibilities
  • Lead Projects as a Project Manager to improve Supplier Quality Processes to improve efficiency and address compliance gaps.
  • Compile key Quality Agreements for Business Expansion with Agilent's Partners.
  • Own Supplier Quality processes including Supplier Quality, Supplier Selection, Evaluation and Re-Evaluations, SCAR Process and Supplier Monitoring as a Global Business Process Owner.
  • Run Supplier Monitoring Boards with cross-functional stakeholders presenting the status of Supplier Quality health with metrics on Audits, SCARs, Supplier nonconformances and ASL.
  • Work with Regulatory affairs/Quality Systems team and Periodically analyze and review Supplier Quality processes to stay in compliance with latest applicable Regulations and Standards.
  • Lead internal CAPAs related to Supplier Quality.
  • Lead high visibility SCARs and Key Supplier Audits (Evaluations and Re-Evaluations) as a Lead Auditor.
  • Guide Procurement on ASL maintenance and Supplier Qualifications and Inactivations.
  • Support Internal and External Audits (FDA, MDSAP, IVDR etc.) representing Supplier Quality in Audit Front rooms.
  • Be a technical custodian of Supplier Data Monitoring and Analysis. Analyze and prepare data for Supplier Monitoring Boards and monitor tools and dashboards for accuracy.
  • Review and Approve Product SCARs, Supplier Change Requests and Quality Agreements.
  • Provide Guidance to International Agilent Sites on Local/Regional Supplier Quality execution and maintenance.
  • Provide guidance to R&D Project teams on Supplier Selection and onboarding.
  • Guide Purchasing department on Quality elements of Supplier Agreement negotiation with Suppliers.
Requirements
  • BS degree in Engineering, Pharma, Biomedical, Health Sciences or equivalent, Masters degree preferred.
  • Minimum 5 years related experience in Supplier Quality and/or Product Quality or related field.
  • Excellent knowledge of 21 CFR part 820, ISO 13485:2016, IVDR, MDSAP regulations (experience in auditing suppliers to these standards).
  • Certified ISO13485:2016 Lead auditor credentials preferred or Completion of a 3rd party certification training for Lead Auditor.
  • Ability to be a true team player and a partner to the cross-functions teams; be part of the solution and demonstrate ability to use sound judgment in implementing practical Quality System and Compliance solutions.
  • Ability to work with highly technical teams and effectively communicate in an engineering-driven team environment.
  • Strong organizational, written, and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment and presentations to executive level management.
  • Excellent Leadership and Project Management skills.
  • Significant computer experience using Windows, Word, Excel, Agile, and SAP.
  • Ability to read and interpret detailed product specifications (reagents, diagnostic devices) and communicate technical information.
What We Offer
  • Competitive compensation and benefits package.
  • Career development opportunities in an international company.
  • Work-Life-Balance is encouraged.
  • Permanent contract in a fast-growing global company.

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