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 114,000 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 in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Irvine, CA location on our EP (Electrophysiology) Quality team.  

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 Qualifications

• Minimum 5 years of related experience in supply chain, planning, or operations.
• Medical device industry experience preferred.
• Demonstrated supervisory or leadership experience.
• Background in engineering and use of quality tools/methodologies.
• Strong knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.
• Experience with SAP and maintaini