We are looking for an experienced Quality Assurance Engineer I – Design Quality Focus to support New Product Development and Sustaining Product Development initiatives within a highly regulated engineering environment. The ideal candidate will have a strong background in Design Quality Engineering, Quality Assurance, Medical Devices, Biomedical Engineering, or Mechanical Engineering, with hands-on experience in design controls, risk management, quality documentation, and regulatory compliance. The role involves participating in design and manufacturing reviews, generating and reviewing DFMEAs/UFMEAs, conducting risk assessments, reviewing design and development documentation, managing CAPAs, and ensuring compliance with ISO 13485, ISO 14971, FDA, GMP, and other applicable regulatory standards. Candidates should have experience working in Medical Devices, Aeronautics, Automotive, or other highly regulated industries, along with a strong understanding of manufacturing processes, quality systems, technical documentation, and continuous improvement practices.

Key Responsibilities
Design Quality & New Product Development
• Participate in design reviews, manufacturing reviews, and New Product Development (NPD) initiatives as the Design Quality representative.
• Support New Product Development and Sustaining Product Development activities to ensure compliance with quality standards and regulatory requirements.
• Generate, review, and maintain Design Failure Mode and Effects Analysis (DFMEA) and Use Failure Mode and Effects Analysis (UFMEA) documentation.
• Participate in design risk assessments, risk analysis discussions, and risk management activities.
• Review and approve design and development documentation to ensure compliance with internal quality procedures and applicable regulatory standards.
• Provide Design Quality Engineering support throughout product development and lifecycle management. Quality Assurance & Regulatory Compliance
• Serve as a Design Quality Subject Matter Expert (SME) during ISO and FDA audits.
• Ensure compliance with internal and external quality standards, specifications, and regulatory requirements, including ISO 13485, ISO 14971, FDA, GMP, and MDD.
• Author, review, and maintain Standard Operating Procedures (SOPs), quality procedures,



and work instructions governing the Quality Management System (QMS).
• Conduct internal quality audits across the quality system and other business functions.
• Review and evaluate nonconforming materials and determine appropriate dispositions based on cross-functional engineering reviews.
• Support Health Hazard Evaluations and other quality-related investigations. CAPA & Continuous Improvement
• Lead and own Corrective and Preventive Actions (CAPA), ensuring effective investigation, implementation, and closure.
• Analyze trends associated with customer complaints, product failures, and nonconforming materials.
• Identify quality issues, investigate root causes, and implement appropriate corrective and preventive measures.
• Collaborate with cross-functional engineering, manufacturing, and quality teams to drive continuous improvement.
• Work on complex quality engineering projects and other special assignments as required. Manufacturing & Technical Quality
• Apply knowledge of manufacturing processes, including metrology, precision machining, grinding, product cleaning, and sterilization.
• Support manufacturing quality reviews and evaluate product and process compliance against established specifications.
• Apply engineering principles and problem-solving methodologies to resolve complex quality-related issues.
• Maintain accurate quality records and technical documentation. Required Qualifications
• Bachelor’s degree in Biomedical Engineering or Mechanical Engineering, with at least 3+ years of relevant professional experience, including a minimum of 1 year in a design-focused environment (or equivalent combination of education and experience).
• Experience working in Medical Devices, Aeronautics, Automotive, or another highly regulated industry.
• Strong understanding of Design Quality Engineering, Quality Assurance, Design Controls, and Quality Management Systems (QMS).




• Working knowledge of ISO 13485 quality standards and applicable FDA regulatory requirements.
• Hands-on experience with DFMEA, UFMEA, risk analysis, and design risk management.
• Experience reviewing and approving design and development documentation.
• Knowledge of CAPA, root cause analysis, nonconformance management, and internal quality audits.
• Understanding of manufacturing processes, particularly metrology, precision machining, grinding, product cleaning, and sterilization.
• Strong technical writing skills and knowledge of quality documentation best practices.
• Proficiency in Microsoft Office Suite or equivalent productivity tools.
• Excellent analytical, problem-solving, communication, and documentation skills. Preferred Qualifications
• CQE (Certified Quality Engineer), Lean, or Six Sigma certification.
• Advanced knowledge of ISO 14971 and medical device risk management principles.
• Hands-on experience with SolidWorks and SolidWorks ePDM.
• Familiarity with Oracle R12 and Agile PLM.
• Experience supporting FDA and ISO audits in a regulated engineering or medical device environment.
• Strong understanding of product lifecycle management, design quality processes, and regulatory compliance.
• Detail-oriented with solid analytical, organizational, and cross-functional collaboration skills. Travel Requirements
• Willingness to travel up to 10% as required. Physical Requirements
• Ability to sit and stand for extended periods.
• Ability to lift, carry, and pull objects weighing up to 25 lbs. 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.

📌 Quality Assurance Engineer I (Hyderabad)
🏢 BrickRed Systems
📍 Hyderabad