Senior Supplier Quality 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 ​

Our location in Irving, TX currently has an opportunity for a Senior Supplier Quality Engineer. The Senior Supplier Quality Engineer is responsible for activities related to supplier selection, evaluation and integration, component qualifications and supplier performance monitoring and improvements. Contributes to the development, establishment and maintenance of Supplier Quality Engineering methodologies, systems and practices which meet Abbott and regulatory requirements. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs.

What You’ll Work On

• Supplier Selection - Evaluates potential future suppliers and supports supplier selection process with the cross-functional team. Assess potential new suppliers for technical, quality and manufacturing capabilities.

• Specification Acceptance/Design-For-Manufacturability (DFM) reviews – Leads a cross-functional team of design engineering and Quality Engineering to work with suppliers during product development and ensures agreement for manufacturable, cost effective designs. 

• Production Part Approval/Qualification - Approves components for use in products by driving Production Part Approval activities with the suppliers including Gage Repeatability & Reproducibility, Process Capability Analysis , Process Failure Mode Effects Analysis (pFMEA), Control Plans, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), etc.

• Supplier quality issues and continuous improvement - Works with suppliers, design engineers, Supplier Quality and purchasing to lead failure investigations for Supplier Quality issues and works on improvements in quality, yields and cost of the product.

• Performance monitoring and corrective actions - Monitor supplier performance including Incoming failures, manufacturing yields and field failures to drive supplier corrective action Reports (SCARs).

• Development of Process and Quality controls at the supplier - Provides Quality oversight for supplier custom process development and supplier process and quality control plans.

• Supplier Audit management - Supports Supplier evaluation, audit management and related records

• Supplier Quality Agreements – Leads in the evaluation and development of Supplier Agreements with suppliers.

• Non-conforming materials management - Supports incoming Non-Conforming Material Report (NCMR) activities and related corrective and improvement actions with suppliers

• Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

• Provides technical support for the introduction of components from a new supplier. Generates and maintains incoming inspection procedures. Trains inspectors to these procedures. Develops and/or sources inspection tools and equipment. Assists in generating component specifications. Generates test protocols, monitor testing, issue qualification test reports and approve components for use in products. Provides input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.

• Analyzes incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers. Reviews new design specifications and provides input from component quality and manufacturability perspective. Investigates field failures related to supplier materials. Develop corrective action plan where necessary. May supervise inspectors.

Preferred Qualifications

• Bachelor's or master’s degree in one of the following Engineering disciplines: Electrical, Bio-medical, or Mechanical. Master’s Degree preferred.

• 7-10 years of relative professional work experience in Medical Device Quality or in automotive industry.

• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. Six Sigma Black or Green Belt certification.

• Strong knowledge of electromechanical processes and products. Experience working with printed circuit boards, electrical cable assemblies, Optics, pumps, motors, solenoids, sheet metal manufacturing, machined parts (both metal and plastic), and injection molding.

• Professional experience from companies that manufacturing complex electromechanical instruments (e.g., medical device, aerospace, robotics, automotive, commercial vehicle/diesel engine).

• Strong technical writing skills; Polished verbal and written communication skills