We anticipate the application window for this opening will close on - 30 Jan 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.

Medtronic, Warsaw, also known as Warsaw Orthopedics, manufactures Spinal Implants and Brain/ENT components. As a member of Supplier Quality Engineering at Medtronic, Warsaw, you will be responsible for management of external suppliers to Medtronic, Warsaw. 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.

Together with our customers, we are moving spine and cranial surgery from an art to a science.

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.

• 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.

• 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.

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

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

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

• Collaborate 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.

• 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 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.

Must Have: Minimum Requirements

• 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 0+ 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

• Effective verbal and written communication skills

• Ability to interface with internal custome