Onsite QA Specialist, Medical Devices | Houston

Healgen Scientific Limited; Houston (TX); Presencial; USD 60 000 - 75 000; Tempo integral

Resumo da oferta

Healgen Scientific Limited, located in the Houston, TX area, seeks a QA Specialist with strong FDA guidelines and ISO 13485 knowledge to support quality systems for medical devices. This full-time, in-office role focuses on building and maintaining QA processes, ensuring regulatory compliance, and coordinating cross-functional activities.

Responsibilities include CAPA tracking, audits, document control, investigations, and training management.

Qualificações

• 2+ years of relevant experience or 5+ years without degree in Medical Device/Pharmaceutical
• Cross-functional team collaboration
• Strong written and spoken English communications
• Ability to troubleshoot when needed
• Ability to prioritize tasks effectively
• Proactive and takes initiative in daily tasks
• Bilingual candidates with Chinese or Spanish preferred

Responsabilidades

• Archive and store documents with cross-functional team
• Support and track CAPAs, SCARs, non-conformances, deviations, reworks and customer complaints
• Assist investigations and root cause analyses
• Manage document control and change control processes
• Coordinate with process owners to update procedures and draft docs
• Ensure documentation meets internal quality standards
• Data entry and basic statistical analysis
• Support internal and external regulatory audits
• Inspect raw materials, in-process and finished products
• Assist manufacturing with batch release documentation
• Support post-market monitoring of products
• Create and track employee training records
• Assist supplier evaluations and maintenance of Approved Supplier List
• Other duties as assigned

Conhecimentos

Quality Assurance

Document Control

CAPA

Root Cause Analysis

FDA Regulations

ISO 13485

Cross-functional teamwork

English Communication

Training Coordination

Supplier Evaluation

Formação académica

Bachelor's degree in relevant field

Descrição da oferta de emprego

Healgen Scientific Limited, located in the Houston, TX area, seeks a QA Specialist with strong FDA guidelines and ISO 13485 knowledge to support quality systems for medical devices. This full-time, in-office role focuses on building and maintaining QA processes, ensuring regulatory compliance, and coordinating cross-functional activities.

Responsibilities include CAPA tracking, audits, document control, investigations, and training management.