Senior Quality Engineer - Medical Devices & NPI Leadership

EPM Scientific; Minneapolis (MN); On-site; USD 130,000 - 180,000; Full time

Job summary

EPM Scientific is seeking a Principal Quality Engineer to provide technical leadership across product development, manufacturing, and post-market activities. You will ensure compliance with FDA QSR, ISO 13485, and global requirements while guiding risk management and design controls.

The role emphasizes CAPA investigations, process validation, and cross-functional collaboration to deliver high-quality medical devices across the lifecycle. Strong communication and leadership are essential.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 10+ years of quality engineering experience in medical devices.

Responsibilities

• Provide technical leadership across product development, manufacturing, and post-market activities.
• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, MDSAP, and global requirements.
• Lead audits, regulatory inspections, and supplier audits.
• Drive quality system improvements for compliance and effectiveness.
• Partner with R&D for design controls, risk management, and design reviews.
• Lead risk management activities per ISO 14971 and maintain risk files.

Skills

Quality engineering

FDA regulations

ISO 13485

Design controls

Risk management

CAPA investigations

Statistical analysis

Cross-functional leadership

Process validation

Root cause analysis

Education

Bachelor's degree in Engineering

Tools

Statistical analysis software

Quality Management System (QMS) software

CAPA tracking tools

Job description

EPM Scientific is seeking a Principal Quality Engineer to provide technical leadership across product development, manufacturing, and post-market activities. You will ensure compliance with FDA QSR, ISO 13485, and global requirements while guiding risk management and design controls.

The role emphasizes CAPA investigations, process validation, and cross-functional collaboration to deliver high-quality medical devices across the lifecycle. Strong communication and leadership are essential.