Supplier Quality Engineer II

Medtronic; United States; Remote; USD 75,000 - 120,000; Full time

Job summary

Medtronic is seeking a Supplier Quality Engineer II to support supplier quality activities for CM and OEM partners, ensuring products meet quality, regulatory and customer requirements. The role involves quality planning, risk assessment, change control and cross-functional collaboration.

Remote role within the United States with up to 15% travel. Requires 2+ years in engineering/quality in a regulated field; a Bachelor’s degree or higher in a technical field is expected.

Qualifications

• Bachelor's degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.
• Experience in medical device, pharmaceutical, biotechnology or other highly regulated industry.
• Advanced degree holders may qualify with 0+ years in Engineering/Quality.

Responsibilities

• Manage supplier quality relationships with CM, OEM and sub-tier suppliers to ensure compliance with quality and regulatory requirements.
• Support product and process changes through quality planning, risk assessment, validation and change control.
• Monitor supplier quality performance with metrics and lead improvement initiatives.
• Conduct supplier audits, assessments and business reviews to evaluate quality systems.
• Investigate quality issues and drive root cause analysis and corrective actions with suppliers and internal stakeholders.
• Collaborate with R&D, Quality, Regulatory, Operations and Manufacturing to ensure finished device requirements.

Skills

Quality engineering

Regulatory awareness

CAPA & root cause

Supplier collaboration

Education

Bachelor's Degree in Engineering/Science

Advanced Degree in Engineering/Science

Tools

CAPA Process

Change control

Job description

We anticipate the application window for this opening will close on - 21 Oct 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

This role supports Supplier Quality within Medtronic, partnering with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and sub-tier suppliers to ensure the quality, compliance, and continuous improvement of supplied medical devices and components. The team collaborates closely with Research & Development, Quality, Regulatory, and supplier partners to maintain effective quality systems, support product and process changes, and drive supplier performance across the product lifecycle.

This is a U.S. Remote position. Candidates may be located anywhere within the United States but preference is the Midwest. Travel of up to 15% is required to support supplier visits, audits, business reviews, and cross-functional activities.

The Supplier Quality Engineer II is responsible for managing supplier quality activities for Contract Manufacturers and Original Equipment Manufacturers, ensuring supplied products and processes meet Medtronic quality, regulatory, and customer requirements. This role partners with internal and external stakeholders to support product and process changes, monitor supplier performance, implement corrective actions, and drive continuous improvement across the supply base.

Primary Responsibilities

• Manage supplier quality relationships with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and sub-tier suppliers to ensure compliance with quality and regulatory requirements.
• Support supplier-related product and process changes through effective quality planning, risk assessment, validation, and change control activities.
• Monitor supplier quality performance using established metrics and lead improvement initiatives to address quality, delivery, and compliance concerns.
• Conduct supplier audits, assessments, and business reviews to evaluate quality system effectiveness and identify opportunities for improvement.
• Investigate quality issues, facilitate root cause analysis, and drive corrective and preventive actions with suppliers and internal stakeholders.
• Partner with Research & Development, Quality, Regulatory, Operations, and Manufacturing teams to ensure supplied products meet finished device requirements.
• Review and approve supplier quality documentation, including nonconformance investigations, corrective actions, process validations, and change notifications.
• Ensure supplier activities comply with applicable medical device regulations, industry standards, and internal quality system requirements.

Required Qualifications

• 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
• Experience working within the medical device, pharmaceutical, biotechnology, or other highly regulated industry.

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

Preferred Qualifications

• Experience working with supplier quality systems, quality audits, corrective and preventive actions (CAPA), and change management processes.
• Experience supporting Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), or external supplier networks.
• Experience supporting regulated products within a quality-controlled manufacturing environment.
• Knowledge of root cause analysis methodologies and continuous improvement tools.
• Knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and risk management principles.
• Experience conducting supplier audits and leading supplier quality improvement initiatives.
• Certification as a Quality Engineer, Auditor, or related quality professional certification.

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 enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the