Senior Supplier Quality Engineer

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 113,000 colleagues serve people in more than 160 countries.

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Irving, TX, currently has an opportunity for a Senior Supplier Quality Engineer within Core Diagnostics.

WHAT YOU’LL DO

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.

Main Responsibilities

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

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

• 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 Failure Mode Effects Analysis (PFMEA), Installation Qualification, Operational Qualification, Performance Qualification, Process Capability Analysis (PCA), 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’s 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

EDUCATION AND EXPERIENCE YOU’LL BRING

Minimum Requirements:

• Apprenticeship or Bachelors degree 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 40% domestically (some international travel also required).

Preferred Requirements:

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

• 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, pumps, motors, solenoids, sheet metal manufacturing, machined parts (both metal and plastic), or injection molding are all desired

• Candidates should possess 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

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives, and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: [Register to View]

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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