Supplier Quality Engineer - Senior

Abbott; Santa Clara (CA); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Medical Plan

Dental Plan

Vision Plan

HSA

FSAs

Life Insurance

ST Disability

LT Disability

Critical Illness/Insurance

MetLife Benefits

401(k)

Job summary

Abbott in Santa Clara, CA seeks a Senior Supplier Quality Engineer to qualify and manage supplier components for medical devices, ensuring compliance with FDA regulations and design controls.

Role focuses on leading cross-functional supplier teams, validating molding and machining processes, managing CAPAs, non-conformances, and supplier change requests, with hands-on Windchill and basic SolidWorks usage.

Qualifications

• 5+ years of medical device experience.
• Experience qualifying purchased components/materials under FDA regulated environment.
• Familiar with Injection Molding, Machining and Thermoforming.
• Experience validating Injection Molding processes.
• Experience validating Machining processes (CNC, Bridgeport, Swiss Screw, Lathe).
• Ability to process ECOs using Windchill.
• Performs and leads Inspection and Test Method Validations.
• Knowledge of statistics and software (Minitab, JMP).
• Basic knowledge of SolidWorks.
• Experience leading cross-functional supplier and internal meetings.
• Experience supporting and owning Non-Conformance Reports, Supplier Corrective Actions, Root Cause Investigations, CAPAs and Supplier Change Requests.
• Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers.
• Apply sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies.
• Familiar with Design Control requirements.

Responsibilities

• Qualify purchased components and of-the shelf materials under FDA regulations.
• Lead cross-functional supplier and internal teams in audits and meetings.
• Support and own Non-Conformance Reports, SCAs, RCIs, CAPAs and SCRs.
• Develop and manage supplier data agreements and CoCs.
• Apply sound engineering analysis to reduce inspection needs.

Skills

Medical device experience

Statistical methods (Minitab/JMP)

Cross-functional team leadership

Technical communication

Education

Bachelor’s degree in Engineering or related science

Tools

Windchill

Minitab

JMP

SolidWorks

Job description

Title: Supplier Quality Engineer - Senior

Location: Santa Clara, California

Duration: 12 Months

100% Onsite

Description

• 5+ years of medical device experience.
• Bachelor’s degree within an Engineering field or related science-based discipline.
• Experience qualifying purchased customs and of the shelf components/materials under FDA regulated environment.
• Familiar with Injection Molding, Machining and Thermoforming Manufacturing methods.
• Experience Validating Injection Molding Process
• Experience Validating Machining Process (CNC, Bridgeport, Swiss Screw, Lathe etc.)
• Ability to process electronic change orders utilizing Windchill (Create CO to revise specifications or quality documents)
• Performs and leads Inspection and Test Method Validations,
• Knowledge of statistical methods and software such as Minitab or JMP
• Basic knowledge of SolidWorks
• Experience leading cross functional team meetings (suppliers and internal company participants)
• Effective communication and organizational skills (collect/publish meeting minutes, Action items and follow up on them)
• Experience supporting and owning Non-Conformance Reports, Supplier Corrective Actions, Root Cause Investigations, Corrective and Preventive Actions and Supplier Change Requests.
• Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers
• Apply sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies.
• Familiar with Design Control requirements

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.