Sr. Supplier Quality Engineer (Medtech)

Location: Plymouth, MN, US; onsite. Approximately 10% travel required.

Salary: $110,000–$140,000 annually.

Company

hirify.global is a commercial-stage medtech company developing the Edison® System, a non-invasive sonic beam therapy based on histotripsy, with current and planned applications across multiple disease areas.

What you will do

• Lead product inspection strategy, supplier requirements, measurement methodologies, and product release activities.
• Support supplier evaluation, audits, performance monitoring, in-process testing, final testing, equipment control, and process validations.
• Collaborate with Design Assurance and Manufacturing Engineering on risk management, design documentation, design transfer, and production compliance.
• Lead PFMEA development, nonconforming material review, complaint analysis, and assigned CAPA investigations.
• Review Device History Records and maintain quality system procedures, work instructions, and forms.
• Act as a subject matter expert during internal and external audits and inspections.

Requirements

• Bachelor’s degree in engineering or a related technical field.
• 5+ years of progressive quality engineering experience in Supplier Quality, Quality Operations, or Manufacturing Quality.
• Experience in medical devices or another highly regulated manufacturing environment.
• Experience with risk management, nonconforming material, complaint handling, and practical application of statistics.
• Experience with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Strong communication, organization, prioritization, follow-up, and attention to detail.

Culture & Benefits

• Full-time employment with health, dental, and vision insurance.
• Life, short-term disability, and long-term disability insurance.
• 401(k), paid time off, and additional benefits.
• Work in a fast-paced medtech environment combining advanced science with commercial medical applications.