Product Quality Engineer

Cyient; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Cyient in Hyderabad seeks a Product Quality Engineer to lead supplier quality and PPAP activities, ensuring parts and materials meet regulatory and customer requirements.

You will drive CAPA, SCAR, risk assessments, and validation, collaborating with cross-functional teams to support NPI, sustaining engineering, and continuous improvement across the product lifecycle.

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 5–8 years of experience in Product Quality, Supplier Quality, Quality Engineering, or Quality Systems.
• Experience in Consumer Healthcare, Medical Devices, Healthcare Products, or other regulated manufacturing environments.
• Experience supporting NPI, product qualification, validation, supplier quality, and sustaining engineering activities.
• Experience working within cross-functional and global teams.

Responsibilities

• Lead supplier quality activities, including CAPA, SCAR, and root-cause investigations.
• Define incoming inspection requirements and acceptance criteria for purchased components and materials.
• Support PPAP for new product introductions and legacy changes.
• Coordinate cross-functional reviews and approvals for supplier changes and ensure timely implementation.
• Ensure compliance with ISO 9001, ISO 13485, and other quality standards.
• Act as the Quality representative in NPI and Sustaining Engineering projects.

Skills

Quality engineering

Risk management

SPC (statistical process control)

Project coordination

Communication

Education

Bachelor's degree in Engineering/Sciences

Tools

PFMEA

MSA

Control Plans

Root Cause Analysis

Risk Assessments

Job description

• Ensure suppliers consistently deliver quality parts, materials, and services that meet organizational, customer, and regulatory requirements.
• Monitor supplier quality performance using established metrics and drive continuous improvement initiatives.
• Lead and support Supplier Corrective and Preventive Action (SCAR/CAPA) activities, including root cause analysis, corrective actions, effectiveness verification, and closure.
• Assess supplier process, material, equipment, and manufacturing changes for quality, compliance, and regulatory impact.
• Coordinate cross-functional reviews and approvals for supplier changes and ensure timely implementation and closure of change requests.

Product Qualification & Validation

• Lead PPAP (Production Part Approval Process) activities for new product introductions and legacy product changes.
• Apply risk-based process validation methodologies to ensure robust product and manufacturing processes.
• Support qualification and validation activities, including protocol development, execution, reporting, and impact assessments.
• Define incoming inspection requirements and acceptance criteria for purchased components and materials.
• Develop, execute, and support validation of internal inspection and test methods as required.
• Ensure inspection, testing, and validation activities comply with applicable quality standards, regulatory requirements, and industry best practices.
• Act as the Quality representative within NPI and Sustaining Engineering projects.
• Support ongoing project activities by coordinating Quality Plan and Quality Norm planning activities throughout the project lifecycle.
• Review and approve design and development deliverables to ensure compliance with quality and regulatory requirements.
• Provide guidance and consultation to project teams regarding process, quality, validation, risk management, and compliance-related questions.
• Participate in design reviews, risk reviews, verification and validation activities, and design transfer activities.
• Support design changes, product improvements, and sustaining engineering initiatives while ensuring product quality and compliance are maintained.

Continuous Improvement & Quality Excellence

• Analyze quality trends, supplier performance metrics, non-conformance data, and process performance indicators to identify improvement opportunities.
• Drive defect prevention activities through proactive risk assessment and implementation of corrective actions.
• Support Lean Manufacturing and Continuous Improvement initiatives across products, processes, and suppliers.
• Collaborate with engineering, manufacturing, sourcing, and supplier teams to improve product quality, reliability, and operational performance.

Stakeholder Management & Collaboration

The Product Quality Engineer collaborates extensively with cross-functional stakeholders to ensure successful product development, industrialization, commercialization, and post-market support activities. Key stakeholders include:

• Post-Market Surveillance Investigators
• Regulatory Affairs Specialists
• Quality Manufacturing Engineers
• Supplier Quality Engineers
• Reliability Engineers

The PQE serves as a key quality partner throughout the product lifecycle, ensuring alignment between product quality, regulatory compliance, risk management, manufacturing readiness, and customer requirements.

• Strong understanding of Quality Management Systems (QMS) and quality engineering principles.
• Knowledge of Risk Management methodologies and risk-based decision-making.
• Experience with Statistical Process Control (SPC) and data-driven quality improvement.
• Hands-on experience in Process Validation and qualification activities.
• Strong understanding of Supplier Quality Assurance and supplier development processes.
• Experience managing CAPA, non-conformances, and root cause investigations.
• Working knowledge of Production Part Approval Process (PPAP).
• Familiarity with ISO 9001, ISO 13485, and other applicable quality standards and regulations.
• Proficiency in quality tools and methodologies including:
  • PFMEA
  • MSA
  • Control Plans
  • Root Cause Analysis
  • Risk Assessments
• Knowledge of Continuous Improvement, Lean Manufacturing, and quality improvement techniques.
• Strong communication, collaboration, stakeholder management, and project coordination skills.

Education & Experience

• Bachelor's Degree in Engineering, Science, or a related Technical Discipline.
• 5–8 years of experience in Product Quality, Supplier Quality, Quality Engineering, or Quality Systems.
• Experience in Consumer Healthcare, Medical Devices, Healthcare Products, or other regulated manufacturing environments.
• Demonstrated experience supporting New Product Introduction (NPI), product qualification, validation, supplier quality, and sustaining engineering activities.
• Experience working within cross-functional and global teams is highly desirable.