Senior QA Engineer, Medical Devices - Onsite + Relocation

Pop-Up Talent; Charlottesville (VA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

MicroAire is seeking a Senior Quality Assurance Engineer for Medical Devices to support and lead quality activities within a regulated environment. This 100% onsite role in Charlottesville, VA requires collaboration across departments to ensure products meet quality and regulatory requirements throughout development, validation, and manufacturing.

The position emphasizes CAPA, risk management, design control, and continuous improvement, with potential for mentorship and leadership within the QA

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 0–3 years of quality, manufacturing, or engineering experience for QA Engineer; 6+ years for Senior QA Engineer.
• Experience in a regulated manufacturing environment and knowledge of FDA/ISO 13485 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 FDA regulations, ISO standards, company procedures, and other regulatory requirements.
• Support CAPA, complaint investigations, nonconformance investigations, root cause analysis, and corrective action activities.
• Evaluate product and process changes and assess impact on quality, validation status, and regulatory compliance.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, Supply Chain, and Operations teams to drive quality objectives and support product launches.

Skills

Quality Assurance

Design Control

CAPA

Validation

Risk Management

Statistical Analysis

Education

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

Job description

MicroAire is seeking a Senior Quality Assurance Engineer for Medical Devices to support and lead quality activities within a regulated environment. This 100% onsite role in Charlottesville, VA requires collaboration across departments to ensure products meet quality and regulatory requirements throughout development, validation, and manufacturing.

The position emphasizes CAPA, risk management, design control, and continuous improvement, with potential for mentorship and leadership within the QA