Product Quality Engineer

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