Supplier Quality Engineer

About Tata Elxsi

Tata Elxsi combines cutting-edge technology with user-focused design expertise to enable customers to deliver innovative and outstanding user experiences. Their integrated Design and Technology teams assist enterprises in reimagining products and services, covering areas such as strategy, consumer research, service and experience design, technology implementation, integration, and launch.

Role Overview

This position focuses on supporting Sleep & Respiratory Care manufacturing transfer activities through supplier qualification, APQP execution, process validation, supplier quality management, and ongoing production support.

Key Responsibilities

• Collaborate with Development, Manufacturing, Procurement, and Suppliers to evaluate risks and establish Critical-to-Quality (CTQ) standards.
• Lead the creation and completion of APQP deliverables related to supplier onboarding, product transfer, and managing changes.
• Review and assist with PFMEA, Control Plans, Measurement System Analysis (MSA), Statistical Process Control (SPC), Process Validation, and Line Release tasks.
• Support supplier qualification, perform supplier audits, monitor supplier performance, and manage corrective actions.
• Manage the resolution of supplier quality issues utilizing CAPA, SCAR, NCR, 8D methodology, and root cause analysis.
• Assist in Design Transfer and Manufacturing Transfer from source to receiving manufacturing sites.
• Coordinate Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), validation builds, and process readiness.
• Work with cross-functional teams to ensure adherence to quality standards and regulatory requirements during the transfer lifecycle.
• Support New Product Introduction (NPI), sustaining engineering, and implement manufacturing changes.

Required Skills and Experience

• Minimum 5 years experience in Supplier Quality Engineering within Medical Devices or other regulated industries.
• Practical expertise in APQP, PPAP/SPPA, PFMEA, Control Plans, MSA, SPC, and Process Validation.
• Deep understanding of CAPA, SCAR, NCR, Root Cause Analysis, and Supplier Quality Systems.
• Experience with Manufacturing Transfer, Design Transfer, or NPI programs.
• Knowledgeable about ISO 13485 and FDA 21 CFR Part 820 standards.
• Excellent communication and stakeholder management capabilities.

Desired Experience

• Experience with Respironics products.
• Leadership background in Design Transfer or Manufacturing Transfer within respiratory, ventilator, CPAP, or sleep therapy device sectors.

Additional Information

Tata Elxsi offers a full compensation and benefits package and is an affirmative action-equal opportunity employer. They comply with all applicable laws related to recruitment and hiring, and consider all qualified applicants without discrimination. Currently, Tata Elxsi does not mandate COVID-19 vaccination or negative testing for entry to offices or client sites, except where required by law or client policy. Some clients may require proof of vaccination or testing.

Employee Benefits

• Comprehensive healthcare including medical, vision, prescription, and dental coverage.
• Support for family life and work-life balance with medical, commuter, and dependent FSAs, competitive paid time off, sick time, and an Employee Assistance Program.
• Financial benefits such as competitive 401(k) matching with Safe Harbor Plan.
• Employee recognition initiatives.
• Access to an exclusive online discount marketplace.