Supplier Quality Engineer

Supplier Quality Engineer

Requirements

• BS degree in Engineering, Pharma, Biomedical, Health Sciences or equivalent
• 4+ years related experience in Supplier Quality and/or Product Quality or related field
• Knowledge of 21 CFR part 820, ISO 13485:2016, IVDR, MDSAP regulations (experience in auditing suppliers to these standards)
• Ability to travel to Suppliers/other Agilent Sites on an as needed basis (30%) – domestic and international
• Proficient with Windows, Word, Excel, Agile, and SAP
• Ability to read and interpret detailed product specifications (reagents, diagnostic devices) and communicate technical information
• 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
• Leadership and Project Management skills

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

Preferred Qualifications

• Certified ISO13485:2016 Lead auditor credentials preferred or Completion of a 3rd party certification training for Lead Auditor