We anticipate the application window for this opening will close on - 17 May 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.

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

In this exciting role as a Supplier Quality Engineer I you will have responsibility for management of suppliers within the Plymouth, MN SQE team. You will be accountable for changes to existing supplied products and processes, as well as oversight of performance and improvement activities. 

You will also lead the oversight of supplied products, ensuring conformance to purchased materials or finished devices requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations. 

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

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

• Perform timely investigations into supplier quality issues.  Lead activities related to Material Review Board (MRB), Nonconformance’s (NCMR), Supplier CAPAs and Inspections.

• Responsible for Supplier/Part Setup and Management in multiple applications.

• Coordinate the addition/change of New Suppliers to the Approved Supplier List (ASL).

• 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.

• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

• Support supplier change notices and assess their impact to MTC manufacturing operations, to existing material inventory, to acceptance procedures and part number configurations.

• Stay abreast of applicable regulatory requirements.  Actively seek out opportunities to understand current industry direction. 

• Applies understanding of statistical concepts to monitor suppliers and correct supplier quality issues.

• Drive continuous improvement using such tools as Lean, Six Sigma and Kaizen.  All activities must be performed in compliance with the Quality System.

Must Have: Minimum Requirements

• Bachelor's Degree in Engineering, Science or technical field with 0+ years of work experience required.

Nice to Have

• Supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.

• ASQ Lead auditor certification. 

• Working knowledge of Quality System Regulation (QSR 21 CFR 820) and ISO 13485.

• Strong written and verbal communication skills in the English language.

• Working knowledge of statistical methods associated with six sigma and quality control.

• Ability to maintain a professional and respectful relationship with coworkers and company.

• Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls

• PC skills, MS Office (Word, Excel, PowerPoint and Project).

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enabl