Bean HR Consulting
Website:
beanhr.com
Job details:
Job Title: Advance Quality Engineer (AQE)
Location: Gurugram (Hybrid/Onsite)
Experience: 2–6 Years
Role Overview
We are seeking a detail-oriented Advance Quality Engineer to drive quality assurance activities across new product development. The role focuses on risk management, regulatory compliance, supplier quality, and ensuring product safety and reliability throughout the lifecycle.
Key Responsibilities
- Perform risk management activities in line with ISO 14971 including risk assessments, risk tables, and mitigation strategies
- Develop and maintain Quality Plans, Technical Files, and Device Master Records
- Conduct FMEA and support design and process risk analysis
- Collaborate with cross-functional teams during all phases of New Product Development (NPD)
- Define and implement inspection strategies (incoming, in-process, and final inspection)
- Support supplier selection, qualification, and ongoing quality performance
- Analyze quality data (complaints, scrap, warranty returns) and drive corrective actions
- Ensure compliance with ISO 13485 and 21 CFR 820
- Author and review procedures in line with GMP and quality standards
- Support and lead process validation and product verification activities
- Drive continuous improvement initiatives and resolve quality issues
Required Qualifications
- Bachelor’s degree in Mechanical / Biomedical / Biotechnology Engineering
- 2–6 years of experience in Quality Engineering or related domain
- Strong understanding of Quality Management Systems and regulatory requirements
- Experience in New Product Development processes
- Knowledge of risk management, FMEA, and validation methodologies
Preferred Skills
- Strong analytical and problem-solving abilities
- Effective communication and stakeholder management skills
- Experience working with cross-functional and global teams
- Hands-on experience in quality tools and methodologies
- Ability to lead quality-related projects independently
Key Skills (Priority Order)
- ISO 14971
- ISO 13485 / 21 CFR 820
- FMEA
- New Product Development (NPD)
- Process & Product Validation
- Quality Data Analysis & Problem Solving
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