Role and

Responsibilities:
Recent Product Introduction (NPI) & Sustaining Engineering Support 1.
Act as the Quality representative within NPI and Sustaining Engineering projects. 2.
Support ongoing project activities by coordinating Quality Plan and Quality Norm planning activities throughout the project lifecycle. 3.
Review and approve design and development deliverables to ensure compliance with quality and regulatory requirements. 4.
Provide guidance and consultation to project teams regarding process, quality, validation, risk management, and compliance-related questions. 5.
Participate in design reviews, risk reviews, verification and validation activities, and design transfer activities. 6.
Support design changes, product improvements, and sustaining engineering initiatives while ensuring product quality and compliance are maintained. Product & Supplier Quality Management 1.
Ensure suppliers consistently deliver quality parts, materials, and services that meet organizational, customer, and regulatory requirements. 2.
Monitor supplier quality performance using established metrics and drive continuous improvement initiatives. 3.
Lead and support Supplier Corrective and Preventive Action (SCAR/CAPA) activities, including root cause analysis, corrective actions, effectiveness verification, and closure. 4.
Assess supplier process, material, equipment, and manufacturing changes for quality, compliance, and regulatory impact. 5.
Coordinate cross-functional reviews and approvals for supplier changes and ensure timely implementation and closure of change requests. Product Qualification & Validation 1.
Lead PPAP (Production Part Approval Process)



activities for new product introductions and legacy product changes. 2.
Apply risk-based process validation methodologies to ensure robust product and manufacturing processes. 3.
Support qualification and validation activities, including protocol development, execution, reporting, and impact assessments. 4.
Define incoming inspection requirements and acceptance criteria for purchased components and materials. cyient.com 5.
Develop, execute, and support validation of internal inspection and test methods as required. 6.
Ensure inspection, testing, and validation activities comply with applicable quality standards, regulatory requirements, and industry best practices. Continuous Improvement & Quality Excellence 1.
Analyse quality trends, supplier performance metrics, non-conformance data, and process performance indicators to identify improvement opportunities. 2.
Drive defect prevention activities through proactive risk assessment and implementation of corrective actions. 3.
Support Lean Manufacturing and Continuous Improvement initiatives across products, processes, and suppliers. Stakeholder Management & Collaboration Collaborates extensively with cross-functional stakeholders, include, R&D; Engineers, Post-Market Surveillance team, Risk Management Engineers, Product Support Engineers, Regulatory Affairs Specialists,



Quality Manufacturing Engineers, Product Industrialization Engineers, Supplier Quality Engineers, Reliability Engineers, etc. Education &

Experience:
1.
Bachelor's degree in Mechanical, Electrical, Electronics, Mechatronics, Biomedical, Manufacturing Engineering, or a related technical discipline. 2.6-8 years of experience in product quality, design quality, supplier quality, manufacturing quality, or quality engineering within medical devices or another highly regulated industry. 3.
Hands-on experience supporting an electromechanical product through NPI, verification/validation, design transfer, production ramp, and sustaining engineering. 4.
Working knowledge of ISO 13485 and ISO 14971, plus applicable regulatory quality-system requirements such as US FDA 21 CFR Part 820/QMSR and EU MDR 2017/745. 5.
Knowledge of applicable standards such as IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 62304, IEC 62133-2, ISO 15223-1, and packaging/transport standards. 6.
Practical experience with design controls, CAPA, nonconformance, change control, process validation, supplier controls, and complaint or post-market feedback processes. 7.
Proficiency with DFMEA/PFMEA, control plans, MSA/Gage R&R;, SPC, process capability, root-cause analysis, sampling plans, and risk-based validation. 8.
Ability to interpret engineering drawings, GD&T;, specifications, test data, tolerance analyses, and component/process capability evidence. 9.
Experience with handheld or portable medical devices containing motors/actuators, rechargeable batteries, PCBAs, sensors, user controls, or fluid/air pathways.

📌 Product Quality Engineer (Hyderabad)
🏢 Cyient
📍 Hyderabad