Supplier Quality Engineer I

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, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Component QA Engineer
 

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Develops, supports and approves acceptance criteria for materials and component qualification at the supplier including all applicable validation activities. Supporting improvement and corrective action in the quality of components sourced from outside suppliers. Provides quality input in the selection of suppliers. Provides technical and quality support to drive supplier corrective action, manufacturing yield issues and process improvements. Project focused, specifically on components for NPI, supplier resilience, GMI. Component QA Engineer role is integral to new supplier/component development. Supports component risk management processes with suppliers.

What You'll Work On

• Support New Product Introduction (NPI) and components projects, work with R&D and Global Engineering engineers and suppliers to optimize design drawings and supplier manufacturing processes so that high quality parts are consistently delivered.
• Provide quality engineering oversight, support and consultancy to suppliers on process validations, design for manufacture (DFM), material selection, and process development.
• Identify and prioritize parts (components and assemblies) requiring supplier development activities.
• Review, understand and incorporate technical design risk assessments into the part evaluation process.
• Support, develop and approves applicable Component Validation activities at suppliers, including but not limited to IQ, OQ, PQ, VMP and Test Method Validation
• Support, develop, approves and owns Supplier Change Notification (SCN) for applicable component and supplier related changes. Ensures applicable evidence is reviewed and approved and CFT inputs to ensure changes are appropriately qualified.
• Support the component quality aspects of Problem Solving, Failure Analysis, and Corrective and Preventative Actions with suppliers. Promote a culture of structured problem solving with suppliers.
• Monitor and control the progress of supplier engineering projects to ensure sound application of quality and engineering principles are used and design intent is being followed. Assist Global Engineering and suppliers to develop Component Failure Modes and Effects Analysis (CFMEA).
• Assist suppliers in developing Component Metrology and QC test requirements to ensure products meet specifications. Work with the applicable Incoming Quality Control departments to evaluate parts and resolve issues.
• Provide quality support to supplier resilience, GMI, capacity expansion and continuous improvement initiatives.
• Escalate potential supplier manufacturing and compliance issues. Travel to supplier sites as necessary.
• Provide quality and technical support in failure analysis, re-design and drawing updates for discrepant production components, assemblies and field returns.
• Cognitive Skills- Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Planning/Organization- Plans, organizes,