Supplier Quality Engineer

Tata Consultancy Services; United States; Hybrid; MXN 400,000 - 650,000; Full time

Benefits offered by this job

Major Medical Insurance

Life Insurance

Grocery Vouchers

Christmas Bonus

Vacation days (MX)

Profit Sharing (PTU)

Job summary

Tata Consultancy Services seeks a Supplier Quality Engineer to support supplier qualification, quality management, and compliance across supplier lifecycle. You will collaborate with Procurement, Engineering, Manufacturing, QA, and Regulatory Affairs to evaluate suppliers, manage ASL, support PPAP, and drive supplier quality performance while ensuring regulatory compliance.

The role requires 4+ years in supplier quality, experience with ASL, PPAP, IQ/OQ/PQ, and knowledge of ISO 13485 and FDA 21

Qualifications

• +4 years of experience as a Supplier Quality Engineer.
• Experience creating and maintaining Approved Supplier Lists (ASL).
• Experience leading or reviewing PPAP submissions.
• Experience reviewing IQ/OQ/PQ documentation.
• Knowledge of risk-based decision-making principles (ISO 14971).
• Familiarity with QMS/PLM platforms (TrackWise, Agile, Windchill, SAP).
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.

Responsibilities

• Maintain and manage the Approved Supplier List (ASL) including supplier qualification and lifecycle management.
• Conduct supplier evaluations, quality system assessments, and compliance reviews.
• Perform supplier audits, including onsite, remote, and desktop assessments.
• Lead or support PPAP submissions and supplier validation activities.
• Review IQ/OQ/PQ documentation.
• Evaluate supplier change requests and assess quality, regulatory, and business risks.
• Participate in root cause investigations, CAPA, and continuous improvement.
• Support audit readiness for internal, customer, and regulatory assessments.

Skills

Supplier Quality Engineer

ASL management

PPAP submissions

IQ/OQ/PQ documentation

Risk-based decision making

QMS & PLM familiarity

English proficiency

Spanish proficiency

Audits & CAPA

Tools

TrackWise

Agile

Windchill

SAP

Job description

TCS is seeking a Supplier Quality Engineer to support supplier qualification, quality management, and compliance activities, ensuring that suppliers meet applicable quality, regulatory, and operational requirements throughout their lifecycle.

The Supplier Quality Engineer collaborates with Procurement, Engineering, Manufacturing, Quality Assurance, and Regulatory Affairs functions to evaluate suppliers, manage Approved Supplier Lists (ASL), support PPAP activities, conduct supplier quality audits, and drive supplier quality performance while maintaining compliance with applicable quality and regulatory standards.

Key Responsibilities:

• Maintain and manage the Approved Supplier List (ASL), including supplier qualification and lifecycle management activities.
• Conduct supplier evaluations, quality system assessments, and compliance reviews.
• Perform supplier audits, including onsite, remote, and desktop assessments.
• Lead or supportProduction Part Approval Process (PPAP) submissions and supplier validation activities.
• Review process validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Evaluate supplier change requests and assess associated quality, regulatory, and business risks.
• Participate in root cause investigations, CAPA activities, and continuous improvement initiatives.
• Support audit readiness activities related to internal, customer, and regulatory assessments.

Qualifications & Experience

• +4 years of experience as a Supplier Quality Engineer or similar positions.
• Experience creating and maintaining Approved Supplier Lists (ASL).
• Experience leading or reviewing PPAP submissions.
• Experience reviewing process validation activities, including IQ/OQ/PQ documentation.
• Knowledge of risk-based decision-making principles aligned with ISO 14971.
• Familiarity with QMS and PLM platforms such as TrackWise, Agile, Windchill, or SAP.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Professional proficiency in English and Spanish.

Location

Work Model

Hybrid.

• Major Medical Insurance.
• Life Insurance.
• Grocery Vouchers.
• Christmas Bonus.
• Vacation days according to Mexican labor law.
• Profit Sharing (PTU).

Other Considerations:

Tata Consultancy Services is an equal opportunity employer. Our commitment to diversity and inclusion drives us to provide equal opportunities to all candidates who meet our required knowledge and competency needs—regardless of socio-economic background, race, color, national origin, religion, sex, gender identity, age, marital status, disability, sexual orientation or any other characteristic.