Senior Supplier Quality Engineer – Medical Devices

Tata Consultancy Services; El Paso (TX); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Discretionary Annual Incentive

Comprehensive Medical Coverage

Family Support: Parental Leaves

Insurance Options: Auto & Home

Job summary

Tata Consultancy Services is seeking a Senior Supplier Quality Engineer in El Paso, TX to lead supplier qualification, audits, and PPAP activities for critical components. You will ensure GMP-compliant processes, manage ASL and SCR evaluations, and coordinate with Procurement, Engineering, and QA to resolve supplier quality issues.

Experience with medical device components,IQ/OQ/PQ, and QMS/PLM systems is preferred; the role requires strong analytical and cross-functional collaboration skills in

Qualifications

• Experience in supplier qualification, approval, lifecycle management.
• Experience conducting supplier quality system audits (on site/remote/desktop).
• Leading or reviewing PPAP submissions for medical device components.
• Knowledge of IQ/OQ/PQ process validations for supplier processes.
• Risk-based decision making aligned with ISO 14971.
• Strong root cause analysis and problem solving skills.
• Familiar with electronic QMS/PLM systems: TrackWise, Agile, Windchill, SAP.
• Collaborates with Procurement, Engineering, Manufacturing, QA, Regulatory.
• Manages multiple suppliers and PPAPs in a regulated environment.
• Ensures suppliers deliver quality parts, materials, and services.
• Qualifies suppliers per company standards; may administer Certified Supplier Program.
• Monitors parts from acquisition through manufacturing; CAPA handling.
• Auditing scheduling to ensure GMP and quality standards.
• Evaluates supplier internal functions for performance feedback.
• Pre-Market QA support for NPD with Component Eng and Post-Market teams.
• Defines Receiving Inspection requirements and test method validation.
• Maintains the Approved Supplier List (ASL).

Responsibilities

• Main tain and update the Approved Supplier List (ASL), including supplier addition, re approval, suspension, or disqualification.
• Conduct supplier evaluations including quality system assessments, technical capability reviews, and regulatory compliance checks.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and Supplier Quality requirements.
• Collaborate with Procurement and Operations to ensure only ASL approved suppliers are used for sourcing and production.
• Define PPAP scope and level based on component risk, regulatory impact, and supplier maturity.
• Act as the PPAP focal point for suppliers, ensuring timely and complete submission of PPAP packages.
• Ensure process validations (IQ/OQ/PQ) are completed when applicable for critical or special processes.
• Evaluate SCRs for quality, regulatory, and risk impact
• Participate in root cause analysis, CAPA activities, and continuous improvement initiatives.
• Support readiness for internal, customer, and regulatory audits.
• Collaborate with Manufacturing, Engineering, and Supplier Quality teams to resolve quality issues promptly.

Skills

Supplier Qualification

ASL Management

PPAP Submissions

IQ/OQ/PQ

Risk Management

Root Cause Analysis

QMS/PLM Systems

Cross-Functional

Supplier Communication

Education

Bachelor of Technology

Tools

TrackWise

Agile

Windchill

SAP

Job description

Tata Consultancy Services is seeking a Senior Supplier Quality Engineer in El Paso, TX to lead supplier qualification, audits, and PPAP activities for critical components. You will ensure GMP-compliant processes, manage ASL and SCR evaluations, and coordinate with Procurement, Engineering, and QA to resolve supplier quality issues.

Experience with medical device components,IQ/OQ/PQ, and QMS/PLM systems is preferred; the role requires strong analytical and cross-functional collaboration skills in