Senior Supplier Quality Leader: Drive QMS & Suppliers

Terumo Medical Corporation; Caguas (PR); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Onsite role with limited remote work

Résumé du poste

Terumo Medical Corporation is seeking a Supplier Quality Manager to lead the supplier quality program across Manufacturing, R&D, Supply Chain, and Quality Engineering, ensuring purchased components meet specifications and regulatory requirements.

The role requires seven years in supplier quality, knowledge of QA methods, and bilingual English/Spanish communication. Onsite work with up to 10% remote is supported, targeting continuous improvement and regulatory compliance in medical devices.

Qualifications

• Experience in medical device supplier quality required.
• Solid understanding of quality systems and CAPA processes.
• Ability to perform supplier evaluations and audits.

Responsabilités

• Lead supplier quality management program across functions (Manufacturing, R&D, Supply Chain, Procurement, Quality Engineering).
• Review new supplier requests and assess impact on QMS and controls.
• Facilitate supplier qualifications, site evaluations, and quality agreements.
• Drive improvements using Six Sigma DMAIC, FMEA, SPC and Lean concepts.
• Manage SCAR process and supplier nonconformance investigations.
• Maintain KPI data and supplier scorecards for continuous improvement.
• Ensure compliance with FDA/regulatory requirements for medical devices.

Connaissances

Medical devices

Quality systems

CAPA & RCA

Bilingual EN/ES

Statistical methods

Formation

Bachelor’s degree in related engineering field

Outils

Excel

QA tools

Description du poste

Terumo Medical Corporation is seeking a Supplier Quality Manager to lead the supplier quality program across Manufacturing, R&D, Supply Chain, and Quality Engineering, ensuring purchased components meet specifications and regulatory requirements.

The role requires seven years in supplier quality, knowledge of QA methods, and bilingual English/Spanish communication. Onsite work with up to 10% remote is supported, targeting continuous improvement and regulatory compliance in medical devices.