Senior QA Engineer - Medical Devices & Validation

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

Job summary

MicroAire Surgical Instruments LLC in Charlottesville, VA is seeking a Quality Assurance Engineer or Senior Quality Assurance Engineer to lead quality 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 compliance with FDA and ISO 13485, drives continuous improvement, and mentors junior staff. Travel and on-site work as needed.

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• 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 for new product development.
• Participate in design verification/validation and risk management.
• Develop and review IQ/OQ/PQ validation protocols and reports.
• Ensure compliance with FDA/ISO standards and QMS.
• Lead CAPA and nonconformance investigations; root cause analysis.

Skills

CAPA management

Design controls

FMEA

Root cause analysis

Statistical analysis

Education

Bachelor's degree in Engineering, Science, or related field

Tools

IQ/OQ/PQ

QMS software

Job description

MicroAire Surgical Instruments LLC in Charlottesville, VA is seeking a Quality Assurance Engineer or Senior Quality Assurance Engineer to lead quality 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 compliance with FDA and ISO 13485, drives continuous improvement, and mentors junior staff. Travel and on-site work as needed.