Medical Quality Engineer

4 weeks ago

Plymouth, Minnesota, United States Abbott Laboratories company Full time

About the Role:

As a Supplier Quality Engineer II at Abbott Laboratories, you will play a critical role in ensuring the quality of our medical devices. You will be responsible for activities related to new product development, supplier selection, evaluation, material qualification, supplier performance, and receiving inspection.

Key Responsibilities:

  • Contribute to the development, establishment, and maintenance of supplier quality engineering methodologies, systems, and practices that meet Abbott and regulatory requirements.
  • Lead the core team supplier quality for EP new product development projects.
  • Provide guidance and training to Purchasing, R&D, Manufacturing, and Quality engineers in applying program requirements.
  • Identify supplier contacts and solicit required documents from suppliers.
  • Conduct phone calls with suppliers as needed to expedite responses or answer questions.
  • Review current Quality Agreements and determine the need to revise.
  • Solicit revised Quality Agreements as determined.
  • Obtain and analyze performance and quality indications information from internal sources for each supplier.
  • Prepare and submit required quality records and documents for closure and filing.
  • Review and approve all supplied product drawings and component quality plans.
  • Manage the development of supplied product inspection procedures and first article requirements.
  • Provide engineering guidance to Abbott Receiving Inspection, including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures.
  • Assess supplier capabilities through direct visits, technical discussions, directed testing, and quality system audits.
  • Proactively communicate quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussions.
  • Evaluate and develop Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers.
  • Apply sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies.
  • 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.
  • Mitigate risk by working with suppliers to document Process Flow Charts, PFMEAs, and Control Plans.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Contribute to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms.

Requirements:

  • BS degree in Engineering or Technical Field or equivalent experience.
  • 2-5 years Medical Device and/or Engineering experience.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong technical writing skills.
  • Engineering experience and demonstrated use of Quality tools/methodologies.
  • 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.

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.

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. 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 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.

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.

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