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Veterans at Abbott

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Abbott Senior Supplier Quality Engineer in Irving, Texas

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 103,000 colleagues serve people in more than 160 countries.

Position Summary

The Supplier Development Quality Engineer is responsible for activities related to supplier selection and evaluation, component qualification, supplier performance 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.

Main Responsibilities

  • Supplier Selection - Evaluates potential future suppliers and supports supplier selection process with the cross-functional team

  • Specification Acceptance/Design-For-Manufacturability (DFM) reviews - Obtains feedback from suppliers during development and ensures agreement for manufacturable, cost effective designs.

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

  • Continuous improvement - Works with suppliers, design engineers, supplier quality and purchasing to implement changes that will improve quality, yields and cost of the product.

  • Performance monitoring and corrective actions - Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

  • Production Part Approval/Qualification - Approves components for use in products by driving Production Part Approval activities including Gage Repeatability &Reproducibility, Installation Qualification, Operational Qualification, Performance Qualification, Process Capability (Cpk analysis), etc.

  • Supplier Audit management - Supports Supplier Audit management and related records

  • Supplier Quality Agreements - Participates 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

Minimum Requirements:

Apprenticeship or Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience. At least 5 years work experience in Quality or related field experience; Has a history of completing successful projects and driving positive compliance outcomes.

  • Must be able to travel 25-50% domestically (some international travel also required).

Preferred Requirements:

  • Bachelor's or master’s degree in one of the following Engineering disciplines: Electrical, Industrial, or Mechanical

  • 10+ years of relative professional work experience in Medical Device Quality

  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

  • Six Sigma Black Belt

  • Strong knowledge of electromechanical processes and products

  • Experience working with printed circuit boards, pumps, motors, solenoids, sheet metal mfg, machined parts (both metal and plastic), or injection molding are all desired

  • Candidates should possess professional experience from companies that mfg complex electromechanical instruments (e.g., medical device, aerospace, robotics, automotive, commercial vehicle/diesel engine)

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

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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