Quality Assurance Coordinator — Medical Devices (ISO 13485)

The West Group Ltd; Garland (TX); Presencial; USD 60.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) with company match

Paid holidays and vacation

Team performance bonus

Descripción de la vacante

The West Group USA in Garland, TX seeks a Quality Assurance Coordinator to lead incoming inspection, maintain process validation, and act as the site quality systems keeper. You will coordinate with production, shipping, and corporate quality to ensure product conformity and regulatory compliance.

This non-management role requires meticulous attention to detail, strong communication, and the ability to work independently while interfacing with multiple teams across the site and corporate

Formación

• 3+ years of quality assurance or quality systems experience in a regulated manufacturing environment (medical device strongly preferred).
• Hands-on experience with incoming inspection using precision tools (calipers, pin gauges, etc.).
• Working knowledge of process validation, cleanroom standards, and quality documentation.
• Strong organizational and communication skills for corporate liaison and complaint handling.
• Proficient with quality systems, ERP, and Microsoft Office.
• High attention to detail and ability to work independently as an individual contributor.
• Bachelor’s degree in a scientific or technical field preferred; ASQ certification a plus.
• Must pass background check, drug screen, and be eligible to work in the U.S.

Responsabilidades

• Approve incoming, in-process, or finished goods by confirming to specification / inspection requirements; conduct tests and reject nonconforming items.
• Document inspection results by completing reports and logs.
• Handle customer/supplier returns; liaise with production manager; close out reports and logs.
• Maintain traceable records and document control.
• Review supplier First Article Inspection reports.
• Investigate quality issues; identify root cause; implement corrective actions (8D).
• Serve as site process keeper for quality procedures and documentation.
• Act as liaison between Garland site and corporate quality.
• Participate in cross-functional investigations of non-conformities (8D/5Y/Ishikawa).
• Maintain and support process validation activities; ensure documentation current.
• Assist in developing and implementing quality standards and control systems.
• Collaborate with other departments on QMS improvements and document support.
• Support internal and external audits, CAPA processes, and CI initiatives.
• Promote CI within the business and team.
• Learn and adhere to operational procedures and systems.
• Lead ISO 13485 and customer quality audits.
• Oversee cleanroom compliance and environmental monitoring programs.
• Provide additional support as required.

Conocimientos

Quality assurance

Quality systems

Medical devices

Incoming inspection

Precision measurement

Process validation

Cleanroom standards

Quality documentation

ERP

Microsoft Office

Attention to detail

Independent contributor

Educación

Bachelor's degree in science/engineering/technical field

ASQ certification (preferred)

Herramientas

ERP systems

Microsoft Office

Descripción del empleo

The West Group USA in Garland, TX seeks a Quality Assurance Coordinator to lead incoming inspection, maintain process validation, and act as the site quality systems keeper. You will coordinate with production, shipping, and corporate quality to ensure product conformity and regulatory compliance.

This non-management role requires meticulous attention to detail, strong communication, and the ability to work independently while interfacing with multiple teams across the site and corporate