Senior Supplier Quality Engineer – Med Devices Leader

Terumo Medical Corporation; Caguas (PR); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Health benefits

401(k) with matching

Paid vacation

Paid holidays

Dental and vision benefits

Job summary

Terumo Puerto Rico, LLC is seeking a Sr. Supplier Quality Engineer to lead supplier management with Manufacturing, R&D, Supply Chain and Quality Engineering to ensure supplier components meet specs.

You will guide Quality Supply Chain teams daily and handle performance and technical issues among staff. The role requires strong knowledge of quality systems, CAPA, and supplier evaluations, with a focus on reducing external and internal failure costs while staying current with FDA/intl regs.

Qualifications

• Bachelor’s or advanced degree in related engineering field or equivalent.
• At least 2 years of supervisory experience.
• Minimum of seven years in supplier approval/management.
• ASQ Quality Engineer or Quality Auditor certification.
• Trained in Six Sigma and Lean methodology; certified as well.
• Experience with medical product quality issues and supplier on-site audits.

Responsibilities

• Lead the supplier management process implementation.
• Review new supplier add requests for impact on quality system and controls.
• Assess supplier suitability via evaluation, questionnaires, quality agreements and site evaluations.
• Collaborate with R&D, Supply Chain and QA to qualify development suppliers.
• Facilitate and perform component/material qualifications and PFMEA/DFMEA support.
• Lead validations and component acceptance activities; identify when gage R&R is needed.
• Drive continuous improvement via Six Sigma, DMAIC, FMEA and Lean methods.
• Manage supplier corrective action requests and supplier metrics.

Skills

People management

Quality systems understanding

Statistical sampling

DOE/PFMEA knowledge

CAPA and root cause analysis

Communication skills

Bilingual English/Spanish

Supplier quality improvement

Education

Bachelor’s or advanced degree in related engineering field

Tools

Excel

Statistical analysis software

Job description

Terumo Puerto Rico, LLC is seeking a Sr. Supplier Quality Engineer to lead supplier management with Manufacturing, R&D, Supply Chain and Quality Engineering to ensure supplier components meet specs.

You will guide Quality Supply Chain teams daily and handle performance and technical issues among staff. The role requires strong knowledge of quality systems, CAPA, and supplier evaluations, with a focus on reducing external and internal failure costs while staying current with FDA/intl regs.