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 Current 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 setting.
- Strong understanding of product lifecycle management, design quality processes, and regulatory compliance.
- Detail-oriented with strong 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