Supplier Quality Engineer

1 month ago

Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full time
Job Description

Agilent Technologies is a leading life science, diagnostic, and applied market laboratory company that provides instruments, services, consumables, applications, and expertise to customers worldwide. We are committed to advancing the quality of life through innovative solutions.

We are seeking a Senior Supplier Quality Engineer to join our team in Denmark. The successful candidate will be responsible for ensuring compliance with various regulations and standards, leading supplier quality compliance projects, developing partner quality agreements, managing high-visibility SCARs, and conducting key supplier audits.

Main Responsibilities
  • Lead projects as a project manager to improve supplier quality processes and address compliance gaps.
  • Compile key quality agreements for business expansion with Agilent's partners.
  • Own supplier quality processes, including supplier selection, evaluation, and re-evaluation, SCAR process, and supplier monitoring as a global business process owner.
  • Run supplier monitoring boards with cross-functional stakeholders to present the status of supplier quality health.
  • Work with regulatory affairs and quality systems teams to analyze and review supplier quality processes to ensure compliance with the latest applicable regulations and standards.
  • Lead internal CAPAs related to supplier quality.
  • Lead high-visibility SCARs and key supplier audits as a lead auditor.
  • Guide procurement on ASL maintenance and supplier qualifications and inactivations.
  • Support internal and external audits, representing supplier quality in audit front rooms.
  • Be a technical custodian of supplier data monitoring and analysis.
  • Review and approve product SCARs, supplier change requests, and quality agreements.
  • Provide guidance to international Agilent sites on local and 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.
Qualifications
  • BS degree in engineering, pharma, biomedical, health sciences, or equivalent; master's degree preferred.
  • Minimum 5 years of 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.
  • 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 partner to cross-functional teams.
  • Ability to work with highly technical teams and effectively communicate in an engineering-driven team environment.
  • Strong organizational, written, and verbal communication skills.
  • Excellent leadership and project management skills.
  • Significant computer experience using Windows, Word, Excel, Agile, and SAP.
  • Ability to read and interpret detailed product specifications and communicate technical information.

Ability to travel to suppliers and other Agilent sites on an as-needed basis (30%) – domestic and international.

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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