Senior Supplier Quality Engineer – Medical Devices (Global)

Saluda Medical; Minnetonka (MN); Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

Saluda Medical, a Minneapolis-based medical device company, seeks a Sr. Supplier Quality Engineer to lead supplier quality activities across qualification, onboarding and monitoring.

You will drive risk assessments, supplier changes, and performance improvements in collaboration with Supply Chain, Engineering and Manufacturing. The role requires 5+ years in quality or manufacturing engineering in regulated industries, a BS in Engineering, and experience with ISO 13485 auditing.

Formación

• BS degree in engineering or a related field.
• 5+ years of quality or manufacturing engineering in medical or regulated industries.
• Strong communication and collaboration skills across functions.
• Experience with supplier management and supplier quality systems.
• Lead auditor experience for ISO 13485 is preferred.

Responsabilidades

• Lead supplier quality activities for qualifications, monitoring and changes.
• Drive supplier performance metrics, CAPAs and corrective actions.
• Conduct supplier quality system audits and risk assessments.
• Support regulatory readiness and internal/external audits.
• Collaborate with Supply Chain, Engineering and Manufacturing to manage supplier risk and improvements.

Conocimientos

Quality engineering

Supplier management

Auditing ISO13485

Cross-functional collaboration

Process improvement

Communications

Travel up to 15%

Educación

BS Degree in Engineering or similar

Descripción del empleo

Saluda Medical, a Minneapolis-based medical device company, seeks a Sr. Supplier Quality Engineer to lead supplier quality activities across qualification, onboarding and monitoring.

You will drive risk assessments, supplier changes, and performance improvements in collaboration with Supply Chain, Engineering and Manufacturing. The role requires 5+ years in quality or manufacturing engineering in regulated industries, a BS in Engineering, and experience with ISO 13485 auditing.