Senior Quality Engineer – Global Device Transfers

Terumo Neuro; Aliso Viejo (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Terumo Neuro in Aliso Viejo, CA is seeking a Sr Engineer, Quality Engineering (Transfers) to support transfer and manufacture of medical devices across global sites. You will collaborate with R&D, NPI, DQE, PQE, and Manufacturing to transfer quality and manufacturing processes from NPD and site-to-site for new and established devices.

The role requires leading and participating in projects to improve existing product lines, resolving quality issues, and supporting CAPA, NCRs, audits, risk

Qualifications

• Minimum four years of quality and/or manufacturing engineering experience in medical devices or other regulated manufacturing.
• Strong interpersonal and written and verbal communication skills.
• Proficient computer skills including MS Word, Excel, Teams, Outlook, and statistical software ( MiniTab ).
• Largely self-directed and proactively motivated.

Responsibilities

• Collaborate with cross functional engineers on developing, transferring, and sustaining robust quality and manufacturing processes across global sites.
• Lead projects to improve effectiveness and efficiency of established product lines.
• Resolve product quality issues and support CAPA, NCR, audits, and quality metrics data analysis.
• Coordinate qualification and maintenance of equipment (IQ/OQ) and review related reports.
• Develop risk analyses, perform test method validations, and analyze data to support manufacturing transfers.
• Support R&D, regulatory, and supply chain to transfer products into production at multiple sites.

Skills

Interpersonal communication

Written and verbal communication

Self-directed

MS Office

Education

Bachelor's degree in engineering

Tools

MiniTab

Job description

Terumo Neuro in Aliso Viejo, CA is seeking a Sr Engineer, Quality Engineering (Transfers) to support transfer and manufacture of medical devices across global sites. You will collaborate with R&D, NPI, DQE, PQE, and Manufacturing to transfer quality and manufacturing processes from NPD and site-to-site for new and established devices.

The role requires leading and participating in projects to improve existing product lines, resolving quality issues, and supporting CAPA, NCRs, audits, risk