Design Quality Assurance Engineer – Medical Devices

BrickRed Systems LLC; Austin (TX); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

BrickRed Systems seeks a highly experienced Quality Assurance Engineer with a design quality focus to support New Product Development and Sustaining Product Development in a regulated medical device environment.

The candidate will lead QA representation on product initiatives, drive CAPA, risk management, and DFMEAs/UFMEAs, and ensure compliance with ISO/FDA requirements across design and manufacturing processes.

Qualifications

• Bachelor’s degree in Biomedical Engineering or Mechanical Engineering.
• 3+ years of engineering experience with at least 1 year in a design-focused environment.
• Experience in a Medical Device, Aeronautics, Automotive, or other highly regulated industry.
• Strong understanding of Design Quality and Quality Assurance principles.
• Experience with ISO 13485 quality standards preferred.
• Strong knowledge of technical writing, quality documentation, procedures, and work instructions.
• Knowledge of manufacturing processes, including metrology, precision machining, grinding, product cleaning.
• Strong understanding of quality systems, compliance, and regulatory requirements.
• Knowledge of Microsoft Office Suite.

Responsabilités

• Participate in design and manufacturing reviews throughout product development activities.
• Generate and review DFMEAs/UFMEAs and participate in risk analysis and risk management discussions.
• Review and approve design and development documentation.
• Serve as a Design Quality Subject Matter Expert during ISO and FDA audits.
• Author and maintain quality system procedures, work instructions, and technical documentation.
• Conduct internal audits of quality systems and other business functions.
• Evaluate nonconforming materials and support disposition decisions through cross-functional engineering reviews.
• Ensure compliance with internal and external specifications, GMP, ISO, FDA, and applicable medical device regulations.
• Review trends associated with device failures, customer complaints, and nonconforming materials.
• Lead and own CAPA.
• Participate in Health Hazard Evaluations and product safety assessments.
• Support New Product Development (NPD) and Sustaining Product Development initiatives.
• Work closely with Engineering, Manufacturing, Quality, and other cross-functional teams.
• Support complex quality and engineering projects as assigned.
• Ensure quality processes and documentation meet regulatory and company requirements.

Connaissances

Design Quality

Quality Assurance

Risk Management

Regulatory compliance

ISO 13485

Technical writing

Manufacturing processes

Microsoft Office

Formation

Bachelor’s degree in Biomedical Engineering or Mechanical Engineering

Outils

SolidWorks

SolidWorks ePDM

Oracle R12

Agile PLM

Description du poste

BrickRed Systems seeks a highly experienced Quality Assurance Engineer with a design quality focus to support New Product Development and Sustaining Product Development in a regulated medical device environment.

The candidate will lead QA representation on product initiatives, drive CAPA, risk management, and DFMEAs/UFMEAs, and ensure compliance with ISO/FDA requirements across design and manufacturing processes.