Design Quality QA Engineer – Medical Devices

BrickRed Systems LLC; Austin (TX); On-site; USD 69,000 - 90,000; Full time

Job summary

BrickRed Systems LLC in Austin, TX is seeking a Quality Assurance Engineer – Design Quality Focus. This role supports New Product Development and Sustaining Product Development in a highly regulated medical device environment.

The ideal candidate has a Biomedical or Mechanical Engineering background, 3+ years of engineering experience in design-focused settings, and hands-on expertise in design quality, risk management, ISO 13485, FDA, and CAPA. Onsite 1st shift, 6-month contract, $55/hr on W2.

Qualifications

• Bachelor’s degree in Biomedical or Mechanical Engineering required.
• 3+ years engineering experience in regulated environments.
• Experience with ISO 13485, FDA and GMP preferred.
• Strong technical writing and documentation skills.
• Knowledge of DFMEA/UFMEA and CAPA processes.

Responsibilities

• Participate in design and manufacturing reviews throughout product development.
• Generate and review DFMEAs/UFMEAs and participate in risk analyses.
• Review and approve design and development documentation.
• Serve as Design Quality SME during ISO and FDA audits.
• Author and maintain quality system procedures and work instructions.
• Lead internal quality system audits.
• Support CAPA, nonconformance, and risk mitigation with cross-functional teams.
• Ensure compliance with GMP, ISO, FDA, and regulatory requirements.

Skills

Design Quality

Quality Assurance

Risk Management

Regulatory Compliance

Technical Writing

Audits

Cross-functional Collaboration

Education

Bachelor's degree in Biomedical Engineering or Mechanical Engineering

Tools

SolidWorks

SolidWorks ePDM

Oracle R12

Agile PLM

Job description

BrickRed Systems LLC in Austin, TX is seeking a Quality Assurance Engineer – Design Quality Focus. This role supports New Product Development and Sustaining Product Development in a highly regulated medical device environment.

The ideal candidate has a Biomedical or Mechanical Engineering background, 3+ years of engineering experience in design-focused settings, and hands-on expertise in design quality, risk management, ISO 13485, FDA, and CAPA. Onsite 1st shift, 6-month contract, $55/hr on W2.