Senior QA Engineer - Medical Devices & Compliance

Enersul Limited Partnership; Charlottesville, Northern (VA, KY); Hybrid; USD 75,000 - 105,000; Full time

Job summary

MicroAire Surgical Instruments LLC is seeking a Quality Assurance Engineer/Senior QA Engineer to lead quality engineering activities across new product development, sustaining engineering, and supplier quality within a regulated medical device environment.

The role partners with cross-functional teams to ensure products meet quality, regulatory, and customer requirements while supporting continuous improvement and operational excellence.

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline is required.
• Experience in a regulated manufacturing environment preferred.
• Knowledge of FDA, ISO 13485, CAPA, validation, and quality systems preferred.

Responsibilities

• Lead/participate in design verification, design validation, risk management, and validation activities.
• Support CAPA, investigations, nonconformances, and root cause analyses.
• Ensure compliance with FDA regulations, ISO standards, and QMS procedures.
• Collaborate with cross-functional teams to drive quality objectives and product launches.
• Mentor junior team members and provide technical quality guidance.

Skills

FDA Compliance

CAPA Management

Change Control

Audit Support

Design Controls

Quality Systems

Risk Management

Education

Bachelor's degree in Engineering, Science, or related technical discipline

Job description

MicroAire Surgical Instruments LLC is seeking a Quality Assurance Engineer/Senior QA Engineer to lead quality engineering activities across new product development, sustaining engineering, and supplier quality within a regulated medical device environment.

The role partners with cross-functional teams to ensure products meet quality, regulatory, and customer requirements while supporting continuous improvement and operational excellence.