Quality Assurance Engineer

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

We are seeking a highly experienced Quality Assurance Engineer – Design Quality Focus to support New Product Development and Sustaining Product Development initiatives within a highly regulated medical device environment. The ideal candidate will have a strong background in Biomedical or Mechanical Engineering, with hands‑on experience in Design Quality, Quality Assurance, Risk Management, ISO/FDA compliance, and regulated product development.

The Quality Assurance Engineer will serve as a key QA representative on product development initiatives and will be responsible for ensuring compliance with internal quality systems, government regulations, and applicable industry standards.

Key Responsibilities

• 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 Corrective and Preventive Actions (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 applicable regulatory and company requirements.

Required Skills

• Bachelor’s degree in Biomedical Engineering or Mechanical Engineering.
• 3+ years of engineering experience, including at least 1 year in a design‑focused environment, or an equivalent combination of education and experience.
• Professional experience within 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 or equivalent productivity tools.
• Strong analytical, problem‑solving, communication, and documentation skills.
• Detail‑oriented with the ability to manage complex quality activities in a regulated environment.

Preferred Skills

• Advanced knowledge of ISO 14971 and medical device risk management principles.
• Experience with SolidWorks.
• Experience with SolidWorks ePDM.Experience with Oracle R12.
• Experience with Agile PLM.
• CQE, Lean, or Six Sigma certification.
• Experience supporting FDA and ISO audits.
• Experience with CAPA, nonconformance, complaint trending, and risk analysis.
• Strong understanding of GMP and medical device quality systems.
• Experience working within New Product Development and Sustaining Engineering environments.

ABOUT BRICKRED SYSTEMS

BrickRed Systems is a global leader in next‑generation technology consulting and workforce solutions, specializing in delivering high‑quality talent across digital, engineering, marketing, analytics, finance, operations, and business transformation domains. With a strong emphasis on innovation, scalability, and client success, BrickRed Systems helps organizations solve complex business challenges by providing skilled professionals across strategy, technology, creative, and operational functions. BrickRed fosters a culture of continuous learning, collaboration, and excellence, enabling professionals to contribute to high‑impact global initiatives while advancing their careers.