Senior Supplier Development Quality Engineer

Working at Abbott

Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application.

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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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 Plymouth, MN location in the EP 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 Senior Supplier Development Quality Engineer, you'll have the chance to provide expertise in 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.

What You’ll Work On

• 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
• Conducts phone calls with suppliers 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
• Prepares and submits required quality records and documents for closure and filing
• 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
• 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, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers
• Applies sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies
• Works with Manufacturing engineering to assess and address purchased product issues
• Participates in or leads teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)
• Mitigates risk by working with the Suppliers to document Process Flow Charts, PFMEAs, and Control Plans
• 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
• Contributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms

Required Qualifications

• BS degree in Engineering or Technical Field or equivalent experience
• 5+ years Medical Device and / or Engineering experience
• 3+ years Supplier Development Engineering experience
• Strong technical writing skills
• Experience with root cause identification and problem solving

Preferred Qualifications

• Advanced degree
• Medical device experience
• Engineering experience and demonstrated use of Quality tools / methodologies
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).

ASQ CQE or other certifications are preferred.

• 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
• ASQ CQE or other certifications

Apply Now

J-18808-Ljbffr