Senior Quality Auditor - Medical Devices & Compliance

Resmed; United States; Remote; USD 68,000 - 102,000; Full time

Benefits offered by this job

Comprehensive medical

Vision insurance

Dental insurance

Life insurance

AD&D

Disability insurance

HSA

FSA

401(k)

Employee stock purchase plan

EAP

Tuition assistance

Job summary

ResMed is seeking a Quality Assurance professional to lead supplier and internal audit activities, drive CAPA investigations, and ensure compliance with FDA and ISO13485 standards. You will partner with QA teams globally to align systems and improve processes across the supply chain.

The role requires regulatory experience, strong communication, and hands-on audit capabilities, with travel up to 10%.

Qualifications

• Bachelor's degree in Engineering or Science.
• Experience with quality systems in a regulated industry.
• Formal audit experience and exposure to CAPA processes.
• Strong communication and stakeholder collaboration skills.

Responsibilities

• Support preparation of supplier and internal audit programs.
• Provide reports on audit status and CAPA programs to management.
• Project manage activities from audit observations and CAPA investigations.
• Liaise with stakeholders to close findings promptly and effectively.
• Represent ResMed in external audits when required and prepare responses.
• Suggest improvements to audit systems and ensure global QA alignment.
• Support QA supplier management and ongoing monitoring for compliance.
• Travel as needed, approximately 10%.

Skills

Bachelor's degree

Quality systems

Audit experience

Communication skills

Regulatory industry experience

Education

Bachelor's degree in Engineering or Science

Job description

ResMed is seeking a Quality Assurance professional to lead supplier and internal audit activities, drive CAPA investigations, and ensure compliance with FDA and ISO13485 standards. You will partner with QA teams globally to align systems and improve processes across the supply chain.

The role requires regulatory experience, strong communication, and hands-on audit capabilities, with travel up to 10%.