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