Tech Lead - Component Cost Estimation, Supplier Mgmt

HCL Technologies Limited; United States; Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Sapsf is seeking a Tech Lead - Component Cost Estimation, Supplier Mgmt to oversee supplier quality activities in the medical device space. The role focuses on ensuring supplier materials and services meet stringent Medtronic standards and regulatory requirements.

Responsibilities include evaluating new suppliers for the Approved Supplier List, performing impact assessments, approving PPAP packages, and coordinating supplier audits and quality agreements with global teams.

Formación

• Bachelor's degree in engineering, Technical, or Scientific discipline.
• Minimum 8 years of experience in Supplier Quality or related roles within the Medical Device industry.
• Strong knowledge of regulatory standards, quality systems, and supplier quality processes.
• Experience with PPAP, risk management, process validation, and quality tools (DFMEA, PFMEA, MSA).

Responsabilidades

• Ensure suppliers consistently deliver quality parts, materials, and services meeting Medtronic requirements.
• Evaluate and onboard new suppliers into the Approved Supplier List (ASL).
• Perform product and feature-level quality impact assessments and maintain necessary documentation.
• Review and approve PPAP documentation including Control Plans, Process Flow Charts, Process Drawings, Capability Studies, DFMEA, and PFMEA.
• Facilitate Supplier Quality Agreements and conduct supplier audits.
• Coordinate supplier evaluation and selection activities for new suppliers or changes to existing products/processes.
• Support and approve Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans.
• Route documentation in PLM systems and follow up for approvals and release.
• Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) / Supplier Owned Quality (SOQ) activities.

Conocimientos

Analytical thinking

Problem solving

Communication skills

Stakeholder management

Cross-functional collaboration

Team collaboration

Educación

Bachelor's degree in engineering/technical/scientific

Herramientas

PLM systems

Quality documentation tools

Descripción del empleo

Career Opportunities: Tech Lead - Component Cost Estimation, Supplier Mgmt (157228)

Supplier Quality Engineer is responsible for ensuring suppliers deliver quality materials, components, and services in compliance with regulatory and organizational requirements within the medical device industry.

Key Responsibilities

• Ensure suppliers consistently deliver quality parts, materials, and services meeting Medtronic requirements.
• Evaluate and onboard new suppliers into the Approved Supplier List (ASL).
• Perform product and feature-level quality impact assessments and maintain necessary documentation.
• Review and approve PPAP documentation including Control Plans, Process Flow Charts, Process Drawings, Capability Studies, DFMEA, and PFMEA.
• Facilitate Supplier Quality Agreements and conduct supplier audits.
• Coordinate supplier evaluation and selection activities for new suppliers or changes to existing products/processes.
• Support and approve Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans.
• Route documentation in PLM systems and follow up for approvals and release.
• Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) / Supplier Owned Quality (SOQ) activities.

Skill Requirements

• Bachelor's degree in engineering, Technical, or Scientific discipline.
• Minimum 8 years of experience in Supplier Quality or related roles within the Medical Device industry.
• Strong knowledge of regulatory standards, quality systems, and supplier quality processes.
• Experience with PPAP, risk management, process validation, and quality tools (DFMEA, PFMEA, MSA).

Other Requirements

• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Ability to work collaboratively with cross-functional and global teams.
• Proficiency in PLM systems and quality documentation tools.