Senior Supplier Quality Engineer

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

Job Description

• Senior Supplier Quality Engineer will support key projects and activities with Critical suppliers in commodities such as Injection Molding, Subassemblies, plastic and other mechanical and electronic components, these activities may include set up acceptance activities, supplier audits, process validations, quality agreements negotiations, Supplier CAPAs as well as Supplier Change Requests (SCR) evaluations and dispositions
• Strong hands on experience in supplier qualification, approval, and lifecycle management.
• Proven capability to create, manage, and maintain Approved Supplier Lists (ASL).
• Hands on experience leading or reviewing PPAP submissions for medical device components.
• Working knowledge of process validation requirements (IQ / OQ / PQ) for supplier processes.
• Strong understanding of risk based decision making aligned with ISO 14971 principles.
• Strong skills in root cause analysis and problem solving methodologies
• Familiarity with electronic QMS / PLM systems (e.g., TrackWise, Agile, Windchill, SAP).
• Ability to work effectively with Procurement, Engineering, Manufacturing, QA, and Regulatory Affairs.
• Strong supplier communication skills (technical discussions, expectations, escalation).
• Ability to manage multiple suppliers and PPAPs simultaneously in a regulated environment.
• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur through the Supplier CAPA process.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering, Post-Market Supplier Quality and Distribution Teams, to deliver quality parts, materials, and services, prevent defects, and allow MiniMed to provide customers with the highest quality and reliable products.
• Define Receiving Inspection requirements as required and associated test method validation
• 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 Supplier Change Requests (SCRs) for quality, regulatory, and risk impact
• Participate in root cause analysis, CAPA activities, and continuous improvement initiatives as required.
• Support readiness for internal, customer, and regulatory audits.
• Collaborate with Manufacturing, Engineering, and Supplier Quality teams to resolve quality issues in a timely manner

Must Have Technical/Functional Skills

• Senior Supplier Quality Engineer will support key projects and activities with Critical suppliers in commodities such as Injection Molding, Subassemblies, plastic and other mechanical and electronic components, these activities may include set up acceptance activities, supplier audits, process validations, quality agreements negotiations, Supplier CAPAs as well as Supplier Change Requests (SCR) evaluations and dispositions
• Strong hands on experience in supplier qualification, approval, and lifecycle management.
• Proven capability to create, manage, and maintain Approved Supplier Lists (ASL).
• Experience conducting supplier quality system audits (on site / remote / desktop).
• Hands on experience leading or reviewing PPAP submissions for medical device components.
• Working knowledge of process validation requirements (IQ / OQ / PQ) for supplier processes.
• Strong understanding of risk based decision making aligned with ISO 14971 principles.
• Strong skills in root cause analysis and problem solving methodologies
• Familiarity with electronic QMS / PLM systems (e.g., TrackWise, Agile, Windchill, SAP).
• Ability to work effectively with Procurement, Engineering, Manufacturing, QA, and Regulatory Affairs.
• Strong supplier communication skills (technical discussions, expectations, escalation).
• Ability to manage multiple suppliers and PPAPs simultaneously in a regulated environment.
• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur through the Supplier CAPA process.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering, Post-Market Supplier Quality and Distribution Teams, to deliver quality parts, materials, and services, prevent defects, and allow MiniMed to provide customers with the highest quality and reliable products.
• Define Receiving Inspection requirements as required and associated test method validation

Roles & 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 Supplier Change Requests (SCRs) for quality, regulatory, and risk impact
• Participate in root cause analysis, CAPA activities, and continuous improvement initiatives as required.
• Support readiness for internal, customer, and regulatory audits.
• Collaborate with Manufacturing, Engineering, and Supplier Quality teams to resolve quality issues in a timely manner

Salary Range:

$80,000 - $100,000 a year

TCS Employee Benefits Summary

• Discretionary Annual Incentive.
• Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
• Family Support: Maternal & Parental Leaves.
• Insurance Options: Auto & Home Insurance, Identity Theft Protection.
• Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
• Time Off: Vacation, Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

Qualifications

BACHELOR OF TECHNOLOGY