Supplier Quality Engineer I - New Product Development

About the position

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Supplier Quality Engineer I, you'll be responsible for activities related to supplier selection, evaluation, re-evaluation, material qualification, supplier performance and receiving inspection. This position contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements.

Responsibilities

• Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements
• Performs re-assessment of suppliers each year per a defined schedule
• Identifies supplier contacts and solicits required documents from suppliers
• Tracks supplier responses and conducts follow-up and escalation as necessary
• Conduct phone calls with supplier as needed to expedite responses or answer questions
• Reviews current Quality Agreements and determines need to revise
• Solicits revised Quality Agreements as determined
• Obtains and analyzes performance and quality indications information from internal sources for each supplier
• Reviews and approves all supplied product drawings and component quality plans
• Manages the development of supplied product inspection procedures and first article requirements
• Provides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures
• 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, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers
• 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

Requirements

• BS degree in Engineering or Technical Field or equivalent experience
• 0-2+ years Medical Device and/or Engineering experience
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects
• Experience with root cause identification and problem solving

Nice-to-haves

• Advanced degree preferred
• Engineering experience and demonstrated use of Quality tools/methodologies
• Strong technical writing skills
• Prior medical device experience

Benefits

• Career development with an international company where you can grow the career you dream of
• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists