Quality Engineer I: Process & CAPA Support

Viant Medical; Vega Baja (PR); On-site; USD 52,000 - 70,000; Full time

Job summary

Viant Medical is seeking an entry-level to intermediate Quality Engineer I to provide technical support for manufacturing and quality systems under established procedures and moderate supervision. You will apply foundational knowledge in Process and Quality Engineering to support manufacturing methods, procedures, and continuous improvement initiatives.

The role involves assisting in investigation of quality issues, supporting audits, and helping develop quality documentation while collaborating

Qualifications

• Bachelor’s degree in Engineering or related discipline.
• Bilingual English/Spanish – Intermediate English level, reading and listening comprehension, writing and oral expression.
• Basic knowledge of statistics (descriptive statistics).
• Basic knowledge of root cause analysis tools.
• Knowledge of Minitab statistics software is a plus.

Responsibilities

• Provide quality support to manufacturing and quality systems under moderate supervision.
• Assist in identification, investigation and resolution of quality-related issues.
• Support/process analysis and improvement activities to enhance efficiency and product quality.
• Develop, review and maintain quality documentation (control plans, FMEAs, specifications).
• Support validation activities with approved protocols (IQ/OQ/PQ).
• Assist in CAPA activities and manage nonconformances under guidance.
• Prepare documentation for internal and external audits.

Skills

Quality Engineering

Communication

Problem Solving

Teamwork

Attention to detail

Self-motivated

Education

Bachelor’s degree in Engineering

Tools

Minitab

ERP

Data collection

Change control

Job description

Viant Medical is seeking an entry-level to intermediate Quality Engineer I to provide technical support for manufacturing and quality systems under established procedures and moderate supervision. You will apply foundational knowledge in Process and Quality Engineering to support manufacturing methods, procedures, and continuous improvement initiatives.

The role involves assisting in investigation of quality issues, supporting audits, and helping develop quality documentation while collaborating