Supplier Quality Engineer - Senior

Location: Santa Clara, California | Duration: 12 Months | 100% Onsite

About the role

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.

Responsibilities

• Qualify purchased custom and off-the-shelf components/materials under FDA regulated environment.
• Validate Injection Molding and Machining (CNC, Bridgeport, Swiss Screw, Lathe, etc.) processes.
• Process electronic change orders utilizing Windchill (create CO to revise specifications or quality documents).
• Perform and lead Inspection and Test Method Validations.
• Lead cross-functional team meetings with suppliers and internal company participants, including collecting/publishing meeting minutes and action items.
• Support and own Non-Conformance Reports, Supplier Corrective Actions, Root Cause Investigations, Corrective and Preventive Actions, and Supplier Change Requests.
• Evaluate and develop 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.
• Familiarity with Design Control requirements.

Requirements

• 5+ years of medical device experience.
• Bachelor’s degree within an Engineering field or related science-based discipline.
• Familiarity with Injection Molding, Machining, and Thermoforming Manufacturing methods.
• Knowledge of statistical methods and software such as Minitab or JMP.
• Basic knowledge of SolidWorks.
• Effective communication and organizational skills.

Benefits

Consultants are eligible for benefits upon waiting period, including:

• 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)