Senior QA Specialist – Medical Devices & Compliance

GT Medical Technologies, Inc.; Washington (District of Columbia); In loco; USD 110.000 - 140.000; Tempo pieno

Descrizione del lavoro

GT Medical Technologies, Inc. is seeking a Senior Quality Assurance Specialist to be located onsite in Richland, WA.

The role drives quality oversight across cross-functional teams involved in design, manufacturing, and testing of medical devices, ensuring compliance with applicable quality and regulatory standards. This position leads QA activities including NC/CAPA, audits, KPI tracking, and process improvements, and supports FDA inspections as a technical resource.

Competenze

• Bachelor's degree in life sciences, engineering, or related field.
• Minimum of 8 years of experience in quality assurance.
• Experience in medical device or pharmaceutical industry.
• Solid understanding of FDA 21 CFR, ISO 13485, and MDSAP.
• Good Manufacturing Practices certification.

Mansioni

• Manage quality support activities for manufacturing and act as quality contact for NC/CAPA systems.
• Ensure compliance with FDA 21 CFR, ISO 13485, and related standards.
• Lead NC/CAPA investigations with root cause analysis and corrective actions.
• Update eQMS logging and drive quality improvements.
• Manage KPIs and present results to management.
• Perform internal process audits and support external audits/inspections.

Formazione

Bachelor's degree in life sciences, engineering, or related field

Strumenti

eQMS

Microsoft Office

Descrizione del lavoro

GT Medical Technologies, Inc. is seeking a Senior Quality Assurance Specialist to be located onsite in Richland, WA.

The role drives quality oversight across cross-functional teams involved in design, manufacturing, and testing of medical devices, ensuring compliance with applicable quality and regulatory standards. This position leads QA activities including NC/CAPA, audits, KPI tracking, and process improvements, and supports FDA inspections as a technical resource.