Remote Supplier Quality Engineer II – Quality & Compliance

Medtronic plc; United States; On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401(k) with match

Tuition Assistance

Job summary

Medtronic is seeking a Supplier Quality Engineer II for a U.S. remote role. You will manage supplier quality activities with CMs, OEMs, and sub-tier suppliers to ensure products meet quality and regulatory requirements. Travel up to 15% may be required.

Collaborate with R&D, Quality, Regulatory, Operations, and Manufacturing to support product and process changes and drive continuous improvement across the supply base.

Qualifications

• Bachelor’s Degree in Engineering/Science or technical field with 2+ years in Engineering and/or Quality.
• Experience in medical device, pharmaceutical, biotechnology, or other highly regulated industry.

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 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 R&D, 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.

Skills

Supplier quality management

CAPA

Audits

Root cause analysis

Regulatory knowledge

Education

Bachelor’s degree in Engineering/Science

Advanced degree in Engineering/Science

Tools

Quality systems knowledge

Job description

Medtronic is seeking a Supplier Quality Engineer II for a U.S. remote role. You will manage supplier quality activities with CMs, OEMs, and sub-tier suppliers to ensure products meet quality and regulatory requirements. Travel up to 15% may be required.

Collaborate with R&D, Quality, Regulatory, Operations, and Manufacturing to support product and process changes and drive continuous improvement across the supply base.