Quality Assurance Associate
SleepRes, a small R&D team developing sleep apnea therapy devices, seeks a QA Associate to run day-to-day Quality Management System operations for Class II medical devices: document control, eQMS administration, training program management, and complaint handling, plus supporting design control, ISO 14971 risk management, and IEC 62304 software records. Requires 3-5 years of medical device quality
- Compensation
- Not disclosed
- Location
- San Francisco - Fremont, United States
- Work setup
- Remote
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- 3+ years
- Category
- Qa
- Posted
Skills
Must have
- 3-5 years of experience in medical device quality or related quality systems work, including Class II medical devices
- Practical experience with document control, training coordination, and electronic document or quality management systems
- Working knowledge of FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, and ISO 13485
- Knowledge of medical device design control, ISO 14971 risk management, and IEC 62304 software lifecycle requirements
- Bachelor's degree in engineering, biomedical engineering, life sciences, quality, or related technical discipline, or equivalent experience
- Strong attention to detail, organization, communication, and follow-through; able to manage multiple assignments and confidential information
Nice to have
- Experience with CPAP or other respiratory therapy devices, connected hardware/software medical devices, or eQMS implementation
- Experience supporting complaint handling, audits, CAPA, or software verification and validation documentation
Full description
About SleepRes
SleepRes is developing next-generation sleep apnea therapy technologies that improve patient outcomes. We are a small, fast-moving R&D team focused on building high-quality medical devices that make a real-world impact.
Position Summary
The Quality Assurance (QA) Associate supports the daily operation and continuous improvement of the Quality Management System (QMS) for Class II medical devices. Reporting to the Quality Manager, this role coordinates document control, manages day-to-day training program activities, administers the electronic QMS (eQMS), and supports customer feedback and complaint handling.
The QA Associate works with Quality, Regulatory, Engineering, Operations, and Customer Care to maintain accurate, complete, and audit-ready records. This is an individual contributor role that supports design control, risk management, and medical device software compliance under the Quality Manager’s direction.
ResponsibilitiesDocument Control
- Administer document control activities within the electronic Quality Management System (eQMS), including document creation, review, approval routing, release, revision, distribution, obsolescence, and archival in accordance with approved procedures.
- Maintain document numbering, revision history, effective dates, controlled templates, and applicable external standards within the eQMS, ensuring obsolete or superseded documents are appropriately controlled and protected from unintended use.
- Review documents and change records for completeness, formatting, required approvals, and associated training assignments; follow up on open actions.
Training Program Management
- Administer the company training program through the eQMS, including maintenance of the training matrix, role-based curricula, onboarding requirements, recurring training, and training triggered by new or revised controlled documents.
- Support onboarding and role changes by ensuring employees are assigned the appropriate eQMS training curricula based on job responsibilities.
- Assign and track training in the eQMS, follow up on overdue assignments, and report completion status to the Quality Manager and department leads.
- Maintain training and competency records, including evidence of training effectiveness where required by procedures.
eQMS Administration
- Support eQMS day-to-day administration, including approved user access, workflows, document and training modules, and user assistance.
- Support controlled configuration changes, data migration, testing, and validation documentation under approved plans; escalate system and data integrity issues.