Senior Supplier Quality Engineer (Remote) – GMP & NPD

Medtronic; United States; Remote; USD 99,000 - 149,000; Full time

Job summary

Medtronic is seeking a Senior Supplier Quality Engineer to lead supplier quality activities with strategic CM/OEM partners across the US. You will drive quality improvements, support product changes, and ensure compliance with GMP and regulatory standards throughout the product lifecycle.

The role may be performed remotely anywhere in the United States, with travel up to 15% for audits, reviews, and cross-functional initiatives.

Qualifications

• Bachelor’s degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality.
• Advanced degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality OR PhD with 0 years relevant experience.
• Experience with supplier quality systems, supplier qualification, supplier audits, or supplier performance management.
• Experience interpreting and applying quality system requirements, technical documentation, specifications, and quality standards.
• Experience supporting Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), or external manufacturing partners within the medical device industry.
• Experience with New Product Development (NPD), product transfers, process validation, design transfer, or supplier onboarding activities.
• Lead Auditor or certified quality-related credential such as ASQ certification.
• Knowledge of ISO 13485, 21 CFR Part 820, GMP, and global medical device regulatory requirements.
• Experience leading supplier corrective actions, continuous improvement initiatives, and cross-functional quality projects.

Responsibilities

• Manage quality oversight of strategic Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and designated suppliers to ensure compliance with product, process, and quality system requirements.
• Lead supplier quality activities associated with product and process changes, including risk assessment, qualification, validation, and implementation support.
• Monitor supplier performance metrics, identify quality risks and trends, and drive corrective and preventive actions to improve supplier effectiveness and product quality.
• Plan, conduct, and support supplier audits to assess compliance with GMP, quality standards, and regulatory requirements.
• Partner with R&D, Regulatory Affairs, Operations, and Quality teams to ensure supplied products meet finished device requirements.
• Investigate supplier-related nonconformances, complaints, and quality issues, facilitating root cause analysis and sustainable corrective actions.
• Provide Supplier Quality support for NPD activities, including supplier qualification, product acceptance strategies, control plans, and supplier deliverables.
• Define and maintain receiving inspection requirements, supplier controls, and quality documentation necessary to support product acceptance and compliance.

Education

Bachelor’s Degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality OR PhD with 0 years relevant experience.

Job description

Medtronic is seeking a Senior Supplier Quality Engineer to lead supplier quality activities with strategic CM/OEM partners across the US. You will drive quality improvements, support product changes, and ensure compliance with GMP and regulatory standards throughout the product lifecycle.

The role may be performed remotely anywhere in the United States, with travel up to 15% for audits, reviews, and cross-functional initiatives.