Supplier Quality Engineer - Senior

Title: Supplier Quality Engineer - Senior

Location: Santa Clara, California

Duration: 12 Month (100% Onsite)

Position Summary

We are seeking an experienced Supplier Quality Engineer with a strong background in medical device manufacturing and FDA-regulated environments. The ideal candidate will have hands-on experience in process validation, supplier quality management, inspection and test method validation, and cross-functional collaboration. This role requires sound engineering judgment, strong analytical skills, and the ability to lead supplier quality initiatives to ensure compliance, performance, and continuous improvement.

Key Responsibilities

• Qualify purchased custom and off-the-shelf components/materials within an FDA-regulated environment.
• Lead and execute Injection Molding and Machining Process Validations (CNC, Bridgeport, Swiss Screw, Lathe, etc.).
• Support and validate manufacturing processes including Injection Molding, Machining, and Thermoforming.
• Perform and lead Inspection and Test Method Validations (TMV).
• Create and process Engineering Change Orders (ECO/CO) in Windchill to revise specifications or quality documents.
• Own and support: Non-Conformance Reports (NCRs), Supplier Corrective Actions (SCARs), Root Cause Investigations, CAPA activities, Supplier Change Requests
• Evaluate and develop supplier quality agreements, including Supplied Data Agreements, Skip Lot Programs, Dock-to-Stock Programs, Certificates of Conformance (CoC), Certificates of Analysis (CoA)
• Apply statistical tools (Minitab, JMP) for data analysis, process capability, and validation studies.
• Reduce inspection requirements through sound engineering analysis aligned with quality and regulatory policies.
• Lead cross-functional meetings with internal stakeholders and suppliers.
• Document and publish meeting minutes, track action items, and ensure timely follow-up.
• Ensure compliance with Design Control requirements and applicable FDA regulations.
• Provide basic CAD support using SolidWorks as required.

Required Qualifications

• Bachelor’s degree in engineering or related science discipline.
• 5+ years of experience in the medical device industry.
• Experience working in an FDA-regulated manufacturing environment.
• Hands-on experience validating: Injection Molding Processes, Machining Processes (CNC, Bridgeport, Swiss Screw, Lathe)
• Proficiency in statistical analysis tools such as Minitab or JMP.
• Experience with Windchill for electronic change order processing.
• Basic knowledge of SolidWorks.
• Strong understanding of Design Controls and regulatory requirements.
• Excellent communication, organizational, and leadership skills.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

 Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.