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Supplier Quality Engineer

  • Job
    Full-time
    Senior Level
  • Engineering
  • United Kingdom, +15
    Remote
  • Quick Apply

AI generated summary

  • You need a BS in Engineering or similar, 5+ years in Supplier/Product Quality, knowledge of relevant regulations, ISO13485 lead auditor cert preferred, strong communication skills, and ability to travel.
  • You will manage supplier quality processes, lead audits and CAPAs, analyze data, guide teams on supplier selection, and ensure compliance with regulations and quality agreements.

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.
  • Ability to travel to Suppliers/other Agilent Sites on an as needed basis (30%) – domestic and international.

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 (as Reseller, Distributor or as any IVDR Economic Operator)
  • 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 Inactivation’s.
  • 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

FAQs

What is the primary role of a Supplier Quality Engineer at Agilent?

The primary role of a Supplier Quality Engineer at Agilent is to ensure compliance with various regulations and standards, lead Supplier Quality Compliance Projects, manage Supplier Quality processes, and conduct key Supplier Audits.

What qualifications are required for this position?

A BS degree in Engineering, Pharma, Biomedical, Health Sciences, or equivalent is required, with a Master's degree preferred. Additionally, a minimum of 5 years of related experience in Supplier Quality or Product Quality is necessary.

What specific regulations should a candidate be knowledgeable about?

Candidates should have excellent knowledge of 21 CFR part 820, ISO 13485:2016, IVDR, and MDSAP regulations, and experience in auditing suppliers to these standards is preferred.

Is travel a requirement for this position?

Yes, the role requires travel to suppliers and other Agilent sites on an as-needed basis, estimated at 30% of the time.

What tools and software experience is preferred for this job?

Significant computer experience using Windows, Word, Excel, Agile, and SAP is preferred for this position.

Will the selected candidate have the authority to lead projects?

Yes, the selected candidate will have the responsibility and authority to lead projects as a Project Manager to improve Supplier Quality Processes and to manage Supplier Quality processes as a Global Business Process Owner.

How does Agilent approach work-life balance for its employees?

Agilent encourages work-life balance and offers career development opportunities in an international company.

Are there any specific certifications that are preferred for applicants?

Yes, certified ISO13485:2016 Lead auditor credentials are preferred, or completion of a third-party certification training for Lead Auditor is also acceptable.

What kind of projects will the Supplier Quality Engineer manage?

The Supplier Quality Engineer will manage Supplier Quality Compliance Projects, high visibility SCARs (Supplier Corrective Action Requests), and conduct key Supplier Audits.

Is this position open to international applicants?

Yes, while the role is based in Denmark or Waldbronn, Agilent encourages qualified applicants from various locations.

Will the Supplier Quality Engineer need to guide other departments?

Yes, the engineer will provide guidance to departments such as Procurement, R&D Project teams, and Purchasing regarding supplier quality and selection processes.

Agilent Technologies

Science & Healthcare
Industry
10,001+
Employees
1999
Founded Year

Mission & Purpose

Analytical scientists and clinical researchers worldwide rely on Agilent to help fulfill their most complex laboratory demands. Our instruments, software, services and consumables address the full range of scientific and laboratory management needs—so our customers can do what they do best: improve the world around us. Whether a laboratory is engaged in environmental testing, academic research, medical diagnostics, pharmaceuticals, petrochemicals or food testing, Agilent provides laboratory solutions to meet their full spectrum of needs. We work closely with customers to help address global trends that impact human health and the environment, and to anticipate future scientific needs. Our solutions improve the efficiency of the entire laboratory, from sample prep to data interpretation and management. Customers trust Agilent for solutions that enable insights...for a better world.