Job Title: Supplier Quality Engineer (SQE)

Department: Supplier Quality- Global Quality and Regulatory Affairs (GQRA)

Reports to: Director, Supplier Quality, Diagnostics and Genomics Group (DGG) Primary Function of Position: Supplier Quality Engineer performs the day-to-day administration of all processes related to Supplier Quality. This role ensures that all Supplier Quality process activities are being performed per Agilents released procedures. S/he will work with cross-functional organizations (Purchasing, Product Quality, RA and R&D) to track records of procedure execution and improve supplier quality processes. Processes to be managed include ASL maintenance, SCARs, Supplier evaluations, Re-Evaluations and supplier monitoring. Roles and Responsibilities: This position has responsibility and authority to:

• Coordinate day-to-day execution of the following processes:
  • Approved Supplier List (ASL) maintenance.
    • Qualifications, Risk Changes and Inactivations and status reports.
  • Supplier Corrective Action Requests (SCAR).
    • Aging, phase execution tracking, and status reports.
  • Supplier Evaluations and Re-Evaluations.
    • Schedule tracking, ownership assignment, record integrity upon closure, and status reports;
  • Supplier Monitoring.
    • Schedule and track Supplier Monitoring Board meetings, track actions taken for resolution of supplier escalations, and compliance to procedural requirements.
• Lead SCARs and Supplier Audits (Evaluations and Re-Evaluations) as a Lead Auditor.
• Identify and implement changes (Continuous Process Improvement) to the above processes and associated procedures and work instructions.
• Globally communicate process improvements.
• Identify and manage exceptions and deviations to the documented procedures for the processes above; this includes verification of completeness and integrity of records generated by process owners.
• Communicate and collaborate with the respective owners of any deviations or exceptions to the procedures or records.
• Collaborate cross-functionally and globally to ensure harmonization of Supplier Quality. This includes (but is not limited to) regular communication all divisional sites.
• Create, analyze, and archive data metrics and records that show objective evidence of the execution of the procedures for the processes above.
• May participate in Regulatory Auditing Body events as SME for procedural and record retrieval associated with Supplier Quality.
• Assist with global harmonization of Supplier Quality procedures and work instruction

Qualifications

Skill/Job Requirements:

• BS degree in Engineering Pharma, Biomedical, Health Sciences or equivalent preferred.
• Minimum 3 years related experience in Supplier Quality or related field.
• Intermediate knowledge of 21 CFR part 820, IVDR, MDSAP and ISO 13485.
• Demonstrated expert experience with process execution and process management.
• Demonstrated experience with global collaboration with internal cross-functional teams.
• Be part of the solution and demonstrate ability to use sound judgment in implementing practical QMS solutions.
• Critical thinking skills and a passion to work in a fast-paced industry with complex and innovative technology.
• Expert organizational, written, and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment. Written and verbal skills include presenting complex data and strategies to global management.

• Expert computer experience with Windows, MS Office, Agile, SAP.
• Experience in a high-volume medical device company is preferred.
• 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.

Location: Manesar, India
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Option to Work Remote

Yes

Travel Required

10% of the Time

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Quality/Regulatory