Supplier Quality Engineer II

Medtronic; Grand Rapids (MI); On-site; USD 85,000 - 115,000; Full time

Job summary

Medtronic in Grand Rapids, MI is seeking a Supplier Quality Engineer II to oversee supplier quality for 600 finished products, including cannulae and beating heart devices. You will drive conformance, MRB/NCMR/CAPA processes, and cross-functional supplier improvements within a regulated medical device setting.

The role requires a technical degree with 2+ years in engineering/quality and knowledge of 21 CFR 820, ISO 13485, and Six Sigma. In-person on-site work is required five days a week.

Qualifications

• Requires a Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality or Advanced Degree with 0+ years of work experience.

Responsibilities

• Ensure that suppliers deliver quality parts, materials, and services.
• Perform timely investigations into supplier quality issues. Lead MRB, NCMR, 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).
• Collaborate with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, ASL coordination, and supplier quality deployment.
• Define Receiving Inspection requirements and test method validation for internal Medtronic methods.
• Support supplier change notices and assess their impact to manufacturing operations and configurations.
• Stay abreast of regulatory requirements and industry direction.
• Apply statistical concepts to monitor suppliers and correct quality issues.
• Drive continuous improvement using Lean, Six Sigma and Kaizen, in compliance with Quality System.

Skills

Lean

Six Sigma

Kaizen

Education

Bachelor’s Degree in Engineering/Science/Technical Field

Advanced Degree in Engineering/Science/Technical Field

Tools

Microsoft Office

MS Project

Job description

We anticipate the application window for this opening will close on - 7 Aug 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Medtronic Mindset challenges us to act boldly, move with urgency, collaborate effectively, and deliver results—the right way. At Medtronic, our most impactful technical leaders bring deep expertise, strong influence, and the ability to drive meaningful improvements across complex supplier networks.

In this exciting role as a Supplier Quality Engineer II, you will have responsibility for management of suppliers within the at our Grand Rapids, MI manufacturing team. You will be accountable for changes to existing supplied products and processes, as well as oversight of performance and improvement activities. The Grand Rapids site manufactures approximately 600 finished products, including cannulae and beating heart products.

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.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

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).

• 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.

• 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.

• Apply 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

• Requires a 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

• Proven supplier quality engineering experience within the medical device industry (or related regulated industry), including expertise in supplier quality management, supplier controls, process validation, auditing, failure investigations, nonconforming product controls, and protocol/report preparation.

• Strong working knowledge of Quality System Regulation (21 CFR Part 820), ISO 13485, statistical quality control methods, and Six Sigma principles.

• ASQ Lead Auditor certification preferred.

• Excellent written and verbal communication skills, with the ability to build and maintain professional, collaborative relationships across all levels of the organization.

• Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, and Project.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4