Quality Auditor - Medical Devices & Regulatory Compliance

ResMed Inc; United States; À distance; USD 68 000 - 102 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits

PTO and holidays

Family leave and caregiver support

Résumé du poste

ResMed Inc. is seeking a Quality Assurance professional to lead and support audit programs across supplier and internal processes for medical devices.

You will provide management with audit and CAPA findings, drive closure of non-conformances, and liaise with stakeholders to ensure continuous improvement and regulatory compliance. The role emphasizes integration with QA teams across ResMed to align systems globally, maintain supplier quality monitoring, and support external audits as needed.

Qualifications

• Bachelor degree in engineering or science required.
• Experience with Quality Systems in a medical or regulated industry.
• Moderate audit experience.
• Excellent communication skills.

Responsabilités

• Support preparation of and implement a comprehensive supplier and internal audit program.
• Provide reports to management on status of audit and CAPA programs.
• Project manage activities from observations and non-conformances.
• Liaise with stakeholders and close findings timely and effectively.
• Support external audits and prepare formal responses for management review.
• Recommend continual improvement of the audit system and QA processes.
• Coordinate QA supplier management and monitoring for compliant supply chain.
• Travel as needed, approximately 10%.

Connaissances

Quality systems experience

Medical device regulatory knowledge

Audit experience

Strong communication

Six Sigma training

Lead/auditor experience

Formation

Bachelor Degree in Engineering or Science

Outils

ISO13485 knowledge

FDA 21 CFR Part 820 knowledge

Description du poste

ResMed Inc. is seeking a Quality Assurance professional to lead and support audit programs across supplier and internal processes for medical devices.

You will provide management with audit and CAPA findings, drive closure of non-conformances, and liaise with stakeholders to ensure continuous improvement and regulatory compliance. The role emphasizes integration with QA teams across ResMed to align systems globally, maintain supplier quality monitoring, and support external audits as needed.