Senior Supplier Quality Engineer - MedTech Compliance Lead

HistoSonics, Inc.; Minneapolis, Saint Paul (MN, MN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health, dental, vision insurance

401(k)

Paid time off

Job summary

HistoSonics, Inc. in Plymouth, MN is seeking a Sr. Supplier Quality Engineer to lead product assurance for commercial production, including inspection, release, nonconforming material handling, and supplier collaboration.

The role partners with Design Assurance to manage risk and transfer design documentation to manufacturing, ensuring compliance with FDA and ISO standards. The ideal candidate has 5+ years in supplier quality or manufacturing quality within medical devices, strong communication,

Qualifications

• Bachelor's degree in engineering or related technical field.
• 5+ years of progressive quality engineering experience in Supplier Quality, Quality Operations, or Manufacturing Quality.
• Experience with FDA 21 CFR Part 820, ISO 13485 and ISO 14971.
• Experience with statistics for product inspection and testing.
• Effective communicator who can work independently and collaboratively across all levels of the organization.
• Approximately 10% travel required.

Responsibilities

• Lead product inspection strategy and planning with suppliers, developing measurement methodologies.
• Support supplier evaluation, auditing, and performance monitoring.
• Support development of in-process and final product testing.
• Support design assurance with risk management updates and design transfer to production.
• Lead PFMEA development and ongoing updates.
• Ensure procedures, practices, and documentation comply with applicable standards and regulations.
• Support transfer of specifications and processes to production during design transfer.
• Lead CAPA investigations and follow-up for assigned CAPAs.
• Review Device History Records (DHR) and complete product release.
• Lead nonconforming material review and documentation.
• Develop and maintain quality system procedures, work instructions, and forms.
• Support internal and external audit activities as needed.

Skills

Quality engineering

Communication

Multitasking

Organization

Risk management

Statistics

FDA 21 CFR Part 820

ISO 13485 / ISO 14971

Education

Bachelor's degree in engineering or related technical field

Job description

HistoSonics, Inc. in Plymouth, MN is seeking a Sr. Supplier Quality Engineer to lead product assurance for commercial production, including inspection, release, nonconforming material handling, and supplier collaboration.

The role partners with Design Assurance to manage risk and transfer design documentation to manufacturing, ensuring compliance with FDA and ISO standards. The ideal candidate has 5+ years in supplier quality or manufacturing quality within medical devices, strong communication,