Medical Device QA & eQMS Specialist

SleepRes, Inc.; San Francisco, Fremont (CA, CA); On-site; USD 70,000 - 95,000; Full time

Job summary

SleepRes, Inc. is developing next-generation sleep apnea therapy technologies. The QA Associate supports the Quality Management System for Class II devices, coordinating document control, training, and eQMS administration under the Quality Manager.

The role collaborates with Quality, Regulatory, Engineering, Operations, and Customer Care to maintain audit-ready records and support design control, risk management, and software lifecycle compliance as directed.

Qualifications

• 3-5 years in medical device quality or related QMS work for Class II devices.
• Experience with document control, training coordination, and electronic QMS.
• Knowledge of FDA QMSR, 21 CFR Part 820, and ISO 13485 requirements.
• Familiarity with design control, risk management (ISO 14971), and IEC 62304.

Responsibilities

• Administer document control within the eQMS and manage approvals, revisions and archives.
• Coordinate training programs, onboarding, and training matrices in the eQMS.
• Support eQMS administration, user access, workflows, and data integrity.
• Log and investigate customer feedback and complaints with traceability.
• Assist design control, risk management, and software lifecycle documentation.
• Support internal/external audits and CAPA with traceable actions.

Skills

Attention to detail

Communication

Organization

Quality mindset

Education

Bachelor’s degree in engineering or related technical discipline

Tools

eQMS

Job description

SleepRes, Inc. is developing next-generation sleep apnea therapy technologies. The QA Associate supports the Quality Management System for Class II devices, coordinating document control, training, and eQMS administration under the Quality Manager.

The role collaborates with Quality, Regulatory, Engineering, Operations, and Customer Care to maintain audit-ready records and support design control, risk management, and software lifecycle compliance as directed.