Senior QA Engineer for Medical Devices & Compliance

MicroAire Surgical Instruments; Charlottesville (VA); On-site; USD 75,000 - 105,000; Full time

Job summary

MicroAire Surgical Instruments LLC seeks experienced Quality Engineers to lead quality activities across new product development, sustaining engineering, supplier quality, and QMS initiatives in a regulated medical device environment.

The role partners with cross-functional teams to ensure products, processes, and systems meet quality, regulatory, and customer requirements while supporting innovation and continuous improvement. Hiring at QA Engineer or Senior QA Engineer level.

Qualifications

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

Responsibilities

• Support and/or lead quality engineering activities related to new product development, design control, and sustaining engineering programs.
• Participate in design verification, design validation, risk management, process validation, packaging validation, sterilization validation, and design transfer activities.
• Develop, execute, and review validation and qualification protocols and reports, including IQ/OQ/PQ activities.
• Ensure compliance with applicable FDA regulations, ISO standards, company procedures, and other regulatory requirements.
• Support and/or lead CAPA, complaint investigations, nonconformance investigations, root cause analysis, and corrective action activities.

Skills

FDA compliance

ISO 13485

CAPA management

Change control

Audit support

Design controls

Statistical analysis

Risk management

Root cause analysis

Education

Bachelor's degree in Engineering, Science, or related

Job description

MicroAire Surgical Instruments LLC seeks experienced Quality Engineers to lead quality activities across new product development, sustaining engineering, supplier quality, and QMS initiatives in a regulated medical device environment.

The role partners with cross-functional teams to ensure products, processes, and systems meet quality, regulatory, and customer requirements while supporting innovation and continuous improvement. Hiring at QA Engineer or Senior QA Engineer level.