Senior Supplier Quality Engineer – Medical Devices (Onsite)

Yoh, A Day & Zimmermann Company; San Diego (CA); On-site; USD 116,000 - 145,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account

401K Retirement Savings Plan

Certification and training

EAP

Job summary

Yoh, a Day & Zimmermann company, is seeking a Senior Supplier Quality Engineer in San Diego onsite to lead supplier quality on cross-functional teams. You will develop material specifications, manage supplier quality, and drive corrective actions.

This role focuses on new materials, supplier qualifications, and changes while ensuring GMP compliance and industry standards. The ideal candidate brings 8+ years QA experience, 5+ years supplier management, and hands-on injection molding/plastics

Qualifications

• Bachelor's degree in biology, chemistry, biochemistry, biomedical engineering or related field.
• 8+ years of QA experience and 5+ years in supplier management.
• Experience with injection molding and plastics required.
• GMP knowledge and supplier/audit experience essential.
• Experience with supplier qualification, SCARs, CAPA and change control.

Responsibilities

• Serve as the primary quality lead on cross-functional teams for materials and supplier changes.
• Develop and execute supplier qualification programs using risk-based approaches.
• Lead supplier audits and manage audit reports and nonconformances.
• Investigate supplier-related issues, determine root cause, and drive CAPA.
• Manage SCARs, communicate nonconformances, and verify effectiveness of actions.
• Review and monitor supplier scorecards and documentation.

Skills

Quality Assurance

Supplier Management

Supplier Audits

CAPA

Root Cause Analysis

Education

Bachelor's degree (Biology, Chemistry, Biochemistry, Biomedical Engineering)

Tools

SAP

MS Office

DMS / EDRMS

Job description

Yoh, a Day & Zimmermann company, is seeking a Senior Supplier Quality Engineer in San Diego onsite to lead supplier quality on cross-functional teams. You will develop material specifications, manage supplier quality, and drive corrective actions.

This role focuses on new materials, supplier qualifications, and changes while ensuring GMP compliance and industry standards. The ideal candidate brings 8+ years QA experience, 5+ years supplier management, and hands-on injection molding/plastics