Senior Engineer Supply Development Quality

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.

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 – $156,000.00. In specific locations, the pay range may vary from the range posted.