Supplier Quality Engineer II

2 days ago

Minneapolis, Minnesota, United States Abbott Full time
About Abbott

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, working together to make a meaningful difference in the lives of our customers and patients.

Job Summary

We are seeking a highly skilled Supplier Quality Engineer II to join our Electrophysiology division in Plymouth, MN. As a key member of our team, you will be responsible for activities related to new product development, supplier selection, evaluation, material qualification, supplier performance and receiving inspection.

You will contribute to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements.

Key Responsibilities
  • Core team supplier quality lead for EP new product development projects
  • Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements
  • 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
  • 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
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Designs and conducts experiments for process optimization and/or improvement
  • Participates in or leads teams in supporting Supplier Development Quality program requirements (e.g., represents the Supplier Development Quality function as a Core Team Member)
  • Mitigates risk by working with 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
  • Performs other related duties and responsibilities, on occasion, as assigned
Requirements
  • BS degree in Engineering or Technical Field or equivalent experience
  • 2-5 years Medical Device and/or Engineering experience
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to leverage and/or engage others to accomplish projects
  • 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
  • Strong technical writing skills
  • Experience with root cause identification and problem solving
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
Preferred Qualifications
  • Advanced degree 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
About Abbott

Abbott is an Equal Opportunity Employer, committed to employee diversity. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call or email [insert contact information].

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