Senior Engineer Supply Development Quality

1003 Abbott Laboratories; Irving (TX); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education benefit

Paid time off

Job summary

Abbott is a global healthcare leader; the Supplier Development Quality Engineer role focuses on supplier selection, evaluation and quality assurance for supplied components. You will oversee material qualification, supplier performance, and receiving inspection, driving quality improvements across the supply chain.

Key responsibilities include coaching technical teams, reviewing supplier drawings, developing inspection procedures, and leading cross‑functional collaboration with Purchasing, R&D,

Qualifications

• Bachelor’s degree in a relevant field.
• Minimum 5 years of experience in a medical device or pharmaceutical field.
• Knowledge of FDA, GMP, ISO 13485, ISO 14971.
• Strong PM and leadership skills with cross‑functional teams.
• Experience with Six Sigma and Lean Manufacturing.
• CAPA experience.

Responsibilities

• Develop, maintain and improve supplier development quality program policies and forms.
• Coach and mentor technical teams as needed.
• Train Purchasing, R&D, Manufacturing and Quality engineers on program requirements.
• Review and approve supplier drawings and quality plans.
• Develop inspection procedures and first article requirements for supplied products.
• Provide guidance to Receiving Inspection including Gage R&R studies and measurement techniques.
• Assess supplier capabilities through visits and audits.
• Report and address quality issues with suppliers via audits and CAPAs.
• Participate in supplier performance reviews and data agreements.
• Apply problem‑solving methodologies to reduce inspection needs.

Skills

FDA compliance

GMP

ISO 13485

ISO 14971

Project management

Leadership

Six Sigma

Lean Manufacturing

CAPA

Preferred medical device experience

Education

Bachelor’s Degree in a relevant field

Master’s Degree (preferred)

Job description

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 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.

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 – $156,000.00 In 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.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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