Med Device QA & Compliance Specialist – Onsite Contract

Ledgent Technology; Tustin (CA); Presencial; USD 47.000 - 66.000; A tiempo parcial

Descripción de la vacante

Ledgent Technology in Tustin, CA is seeking a detail-oriented Quality Compliance Specialist to maintain our QMS for Class II medical devices. The role ensures development, manufacturing, and post-market activities comply with FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR, acting as the primary compliance champion between engineering, operations, and regulatory teams.

This 6-month consulting engagement is 100% onsite, with compensation up to $41 per hour.

Formación

• FDA 21 CFR Part 820, ISO 13485, EU MDR knowledge required.
• Experience with internal/external regulatory audits.
• Proficient in eQMS and electronic databases.
• Strong analytical and documentation skills.

Responsabilidades

• Maintain the QMS for Class II medical devices.
• Bridge engineering, operations and regulatory teams to ensure compliance.
• Support regulatory audits and regulatory submissions as needed.

Conocimientos

Root-cause analysis

Attention to detail

Regulatory communication

Auditing

Educación

Associate degree + 5+ years

Bachelor's degree in science/engineering/medical

ISO Lead Auditor certification

Herramientas

eQMS

Microsoft Word

Excel

PowerPoint

Descripción del empleo

Ledgent Technology in Tustin, CA is seeking a detail-oriented Quality Compliance Specialist to maintain our QMS for Class II medical devices. The role ensures development, manufacturing, and post-market activities comply with FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR, acting as the primary compliance champion between engineering, operations, and regulatory teams.

This 6-month consulting engagement is 100% onsite, with compensation up to $41 per hour.