Senior Supplier Quality Engineer - Medical Devices Leader

Regulatory Jobs; Minneapolis (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Saluda Medical, headquartered in Minneapolis, MN, seeks a Sr. Supplier Quality Engineer to lead supplier qualification, monitoring, audits, and CAPAs for external partners ensuring quality and regulatory compliance in medical devices.

You will collaborate with Quality, Supply Chain, Engineering and Manufacturing to drive supplier performance, risk reduction, and continuous improvement across the product lifecycle.

Qualifications

• BS degree in engineering or similar field.
• Minimum 5 years of quality engineering or manufacturing engineering in medical or regulated industry.
• Experience communicating with cross-functional teams and external suppliers.
• Lead auditor of quality systems (ISO 13485) experience.

Responsibilities

• Develop and maintain collaborative supplier partnerships to ensure materials, components, devices, and services meet quality, regulatory, and performance requirements.
• Serve as the quality lead for supplier-related activities including sustaining engineering projects and supplier change management.
• Establish, monitor, and analyze supplier performance metrics and drive improvement actions.
• Own supplier-related quality events, SCARs, and CAPAs with root-cause analysis and effectiveness verification.
• Plan and conduct supplier quality audits and assessments for regulatory and internal standards.

Skills

Quality engineering

Supplier management

Auditing ISO13485

Communication skills

Travel coordination

Education

BS Degree in Engineering

Job description

Saluda Medical, headquartered in Minneapolis, MN, seeks a Sr. Supplier Quality Engineer to lead supplier qualification, monitoring, audits, and CAPAs for external partners ensuring quality and regulatory compliance in medical devices.

You will collaborate with Quality, Supply Chain, Engineering and Manufacturing to drive supplier performance, risk reduction, and continuous improvement across the product lifecycle.