Quality Assurance Engineer

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
• Sterilization
• 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.