Product Quality Engineer

Job description

Product & Supplier Quality Management • 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. New Product Introduction (NPI) & Sustaining Engineering Support • 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: • R&D Engineers • Post-Market Surveillance Investigators • Risk Management Engineers • Product Support Engineers • Regulatory Affairs Specialists • Quality Manufacturing Engineers • Product Industrialization 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. Required Competencies • 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. Location: Hyderabad, India