Senior Supplier Quality Engineer
About the role
A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. In this exciting role as a Senior Supplier Quality Engineer, you will have responsibility for management of supplier transfers within the Global Supplier Quality Supplier Change Implementation Team.
Responsibilities
- Define component qualification strategy (PPAP), partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness.
- Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures.
- Define control plans to ensure appropriate acceptance activities.
- Execute Product Qualification activities ensuring suppliers are capable of delivering quality products and materials.
- Provide technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle.
- Evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation.
- Develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, and Supplier Owned Quality deployment for transferred products.
Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume. Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in a regulated industry OR PhD with 0 years relevant experience.
Qualifications
Strong knowledge of Supplier Controls, including creation and maintenance of supplier files in the Approved Supplier List (ASL).
Experience with Windchill and Agile PLM systems.
Working knowledge of FDA regulations and ISO standards for implantable and non-implantable medical devices.
ASQ certification preferred, such as CQE, CQA, and/or CSQP.
First Time Quality Coach (FTQ) Six Sigma, DFSS, or Lean Green Belt/Black Belt certified.
Knowledge of PPAP, part/product validation, and qualification processes.
Strong technical knowledge of metrology, measurement techniques, GD&T, measurement uncertainty, Gauge R&R, and statistical analysis using tools such as Minitab.
Demonstrated ability to influence and negotiate with suppliers and lead successful change initiatives.
Strong project leadership skills, including balancing risk and benefit, influencing cross-functional teams, and driving accountability for outcomes.
Excellent communication, organizational, presentation, judgment, and problem-solving skills, with the ability to operate strategically and tactically (especially root cause analysis).
Periodic travel is expected to suppliers or Medtronic facilities. Travel is less than 25%.
Skills
Strong knowledge of Supplier Controls, including creation and maintenance of supplier files in the Approved Supplier List (ASL).
Experience with Windchill and Agile PLM systems.
Working knowledge of FDA regulations and ISO standards for implantable and non-implantable medical devices.
ASQ certification preferred, such as CQE, CQA, and/or CSQP.
First Time Quality Coach (FTQ) Six Sigma, DFSS, or Lean Green Belt/Black Belt certified.
Knowledge of PPAP, part/product validation, and qualification processes.
Strong technical knowledge of metrology, measurement techniques, GD&T, measurement uncertainty, Gauge R&R, and statistical analysis using tools such as Minitab.
Demonstrated ability to influence and negotiate with suppliers and lead successful change initiatives.
Strong project leadership skills, including balancing risk and benefit, influencing cross-functional teams, and driving accountability for outcomes.
Excellent communication, organizational, presentation, judgment, and problem-solving skills, with the ability to operate strategically and tactically (especially root cause analysis).
Benefits
Salary ranges for U.S (excl. PR) locations (USD):$99,200.00 - $148,800.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).