QA Specialist: Medical Devices & Regulatory Compliance

Stratix Corporation; Norcross (GA); Presencial; USD 65.000 - 95.000; Jornada completa

Descripción de la vacante

Stratix Corporation is seeking a Quality Assurance (QA) Specialist to ensure provisioning, configuration, and kitting of medical devices meet regulatory and customer requirements. You will enforce quality systems on the production floor, maintain compliance with ISO 13485, FDA QSR, and HIPAA, and drive continuous improvement through CAPA and risk management.

This role requires hands-on experience with documentation (DHRs/DMRs), traceability, and audit readiness, plus collaboration with suppliers

Formación

• Bachelor’s degree in Quality, Engineering, Life Sciences, or related field.
• Minimum of 2 years of Quality Assurance experience in medical device manufacturing or other highly regulated environments.
• Hands-on experience with Root Cause Analysis (RCA) and CAPA systems.
• Experience with quality documentation and reporting, and regulatory audits.

Responsabilidades

• Monitor provisioning, configuration, and kitting operations on the production floor.
• Perform in-process and final inspections to ensure compliance with specifications and quality standards.
• Maintain traceability of serialized devices and kit components.
• Support regulatory audits and ensure compliance with established quality management systems.

Conocimientos

Analytical thinking

Problem solving

Cross-functional collaboration

Attention to detail

Educación

Bachelor’s degree in Quality, Engineering, Life Sciences, or related field

Herramientas

eQMS

PPAP documentation

Traceability systems

Descripción del empleo

Stratix Corporation is seeking a Quality Assurance (QA) Specialist to ensure provisioning, configuration, and kitting of medical devices meet regulatory and customer requirements. You will enforce quality systems on the production floor, maintain compliance with ISO 13485, FDA QSR, and HIPAA, and drive continuous improvement through CAPA and risk management.

This role requires hands-on experience with documentation (DHRs/DMRs), traceability, and audit readiness, plus collaboration with suppliers