Senior Supplier Quality Engineer

Abbott • Maple Grove, MN

1d • $78,000 - $156,000 • Onsite

About The Position

Senior Supplier Quality Engineer

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 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.

The Opportunity
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 a Senior Supplier Quality Engineer, you'll have the chance to be part of a team of Engineers 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.

Requirements

• BS degree in Engineering or Technical Field or equivalent experience
• 5 + years of Engineering experience in a regulated industry
• Ability to work in a highly matrixed and geographically diverse business environment
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Ability to leverage and/or engage others to accomplish projects
• Strong technical writing skills
• Experience with root cause identification and problem solving

Nice To Haves

• Advanced degree preferred
• Medical device industry experience preferred
• Engineering experience and demonstrated use of Quality tools/methodologies
• 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
• Prior medical device experience
• ASQ CQE or other certifications

Responsibilities

• 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)
• Participate in or lead teams supporting new product development associated to supplier development and management
• Provides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures
• Mitigates risk by working with the Suppliers to document Process Flow Charts, PFMEAs, and Control Plans
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers
• Reviews and approves all supplied product drawings and component quality plans
• Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements
• Performs audits and 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
• Prepares and submits required quality records and documents for closure and filing.
• Manages the development of supplied product inspection procedures and first article requirements
• 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
• 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
• Design and conduct experiments for process optimization and/or improvement
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• Contributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms

Benefits

• 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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level