Senior Engineer Supply Development Quality

Abbott; Irving (TX); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Irving, Texas is seeking a Senior Engineer in Supply Development Quality to drive supplier quality initiatives across the product lifecycle. You will lead supplier selection, evaluation, and continuous improvement activities ensuring compliance with FDA, GMP, ISO 13485, and ISO 14971.

The role requires strong project leadership and collaboration with Purchasing, R&D, Manufacturing, and Quality teams.

Qualifications

• Bachelor's degree required in a relevant field.
• Five+ years of experience in medical device/pharmaceutical quality.
• Strong knowledge of FDA, GMP, ISO 13485, ISO 14971.
• Experience with Six Sigma and Lean Manufacturing.

Responsibilities

• Develop, maintain and improve supplier development quality programs.
• Provide coaching and guidance to cross-functional teams in applying program requirements.
• Review and approve supplied product drawings and quality plans.
• Lead supplier inspections, CAPA, and supplier audits.
• Support Receiving Inspection with statistical analysis and measurement methods.

Skills

Project management

Leadership

Quality engineering

Risk assessment

Process improvement

Education

Bachelor's degree in a relevant field

Master's degree (preferred)

ASQ CQE or other certifications (preferred)

Job description

## Senior Engineer Supply Development QualityApply: United States - Texas - Irving: Full time: Posted Today: End Date: December 7, 2026 (26 days left to apply): 31166801Abbott 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 122,000 colleagues serve people in more than 160 countries.## **JOB DESCRIPTION:****Working at Abbott**At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.* An excellent retirement savings plan with a 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 worldwide and named one of the most admired companies by Fortune.* A company that is recognized as one of the best big companies to work for and a best place to work for diverse, working mothers, female executives, and scientists **The Opportunity**Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements. **What You'll Work On*** Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms.* May provide coaching, and mentoring for technical team personnel.* Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.* Reviews and approves all supplied product drawings and component quality plans.* Manages development of supplied product inspection procedures and first article requirements.* Provides engineering guidance to division Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.* Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.* Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.* Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.* Contributes and participates in supplier performance reviews.* Evaluates and develops Supplied Data Agreement partnerships with suppliers.* Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies.* Works with Manufacturing engineering to assess and address purchased product issues.* Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues* Design and conduct experiments for process optimization and/or improvement* Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)* Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.**Required Qualifcations*** Bachelor's Degree in a relevant field* Minimum of five (5) years of relevant experience in a medical device or pharmaceutical field* Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.* Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner* Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing).* CAPA Experience **Preferred Qualifications*** Masters Degree* Experience working in a broader enterprise/cross-division business unit model preferred.* ASQ CQE or other certifications preferred* Prior medical device experience**The base pay for this position is**$78,000.00 – $156,000.00In specific locations, the pay range may vary from the range posted.## **JOB FAMILY:**Operations Quality## **DIVISION:**CRLB Core Lab## **LOCATION:**United States > Irving : LC-8## **ADDITIONAL LOCATIONS:**## **WORK SHIFT:**Standard## **TRAVEL:**Yes, 10 % of the Time## **MEDICAL SURVEILLANCE:**Not Applicable## **SIGNIFICANT WORK ACTIVITIES:**Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO\\_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO\\_Spanish.pdf