We anticipate the application window for this opening will close on - 7 Apr 2025

 

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.

A Day in the Life

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

As a member of Supplier Quality Engineering at Medtronic Energy and Component Center (MECC), you will be responsible for management of external suppliers to MECC. You will lead oversight of supplied products, ensuring conformance to purchased material requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations.
 

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.

Responsibilities may include the following and other duties may be assigned.

• Ensure that suppliers deliver quality parts, materials, and services.

• Lead cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance issues discovered during incoming inspection.

• Lead and/or participate in corrective/preventive action teams in resolving supplier-related issues (e.g., nonconformances, CAPA activities, audit findings, complaint investigations, etc.).  

• 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.

• Evaluate and act as a lead in processing and approving supplier change requests. 

• Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.

• Evaluate suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the product’s lifecycle. Including implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.

• Develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for existing products.

• Formulate, deliver and/or manage projects assigned and works with other stakeholders to achieve desired results.

• Support internal and external audit and inspections, including preparation and resolution of audit and inspection findings.

• Collaborate cross-functionally with internal stakeholders and interact with multiple levels of personnel internally and externally to ensure timely completion and approvable output of Supplier CAPA records.

Must Have: Minimum 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 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with no years of work experience in Engineering and/or Quality

Nice to Have

• Working knowledge of ISO 13485, ISO 14971, 21CFR820

• Experience in applying DMAIC / Lean Six Sigma principles; Green Belt or Black Belt certification

• Good statistical data analysis skills, including SPC

• Root cause analysis methodology

• Risk Management or CAPA experience

• Experience in Automated Optical Inspe