Senior Supplier Quality Engineer

MedtronicLafayette, CO
Remote

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This position is remote based in Colorado to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 15% of travel to our Lafayette, Colorado site to enhance collaboration and ensure successful completion of projects and 20% of travel to various Contract Manufacturers across north America. As a Senior Supplier Quality Engineer, you will serve as a key member of multiple cross-functional core teams responsible for supporting the production of medical devices across several contract manufacturers supporting Acute Care & Monitoring products. This role is responsible for ensuring all aspects of the manufacturing process produce products to the highest possible reliability and quality. As a Sr. Supplier Quality Engineer level, you will work independently under limited supervision as a seasoned individual contributor addressing difficult challenges at a supplier level. Problem-solving is in-depth, requiring innovative solutions, process improvements, and project or change management skills.

Requirements

  • Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
  • For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
  • The employee is regularly required to be independently mobile.
  • The employee is also required to interact with a computer, and communicate with peers and co-workers.
  • Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

  • Engineering focused Degree
  • Knowledge of FTQ, Lean and 6 Sigma principles
  • Knowledge of Risk Management (DFMEA, PFMEA)
  • Experience with Validation (IQ, OQ, PQ, TMV)
  • Knowledge and experience with manufacturing assembly processes and inspection/testing methods
  • Excellent organization, planning, technical writing, communication, and presentation skills

Responsibilities

  • Ensures that suppliers deliver quality parts, materials, and services.
  • Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
  • Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
  • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
  • Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
  • Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
  • Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
  • Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.

Benefits

  • Health, Dental and vision insurance
  • Health Savings Account
  • Healthcare Flexible Spending Account
  • Life insurance
  • Long-term disability leave
  • Dependent daycare spending account
  • Tuition assistance/reimbursement
  • Simple Steps (global well-being program)
  • Incentive plans
  • 401(k) plan plus employer contribution and match
  • Short-term disability
  • Paid time off
  • Paid holidays
  • Employee Stock Purchase Plan
  • Employee Assistance Program
  • Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
  • Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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