The posting
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.
Responsibilities
Document 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history, effective dates, controlled templates, and applicable external standards within the eQMS, ensuring obsolete or superseded documents are appropriately controlled and protected from unintended use.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.
Feedback and Complaint Support
• Log customer feedback and complaints, obtain missing information, and maintain traceability to the device, serial number, event, and supporting records.
• Coordinate follow-up with Customer Care, Engineering, and Operations; support complaint investigations, record completeness checks, and tracking to closure.
• Promptly escalate potential safety issues and time-sensitive events to Quality and Regulatory for evaluation and reporting decisions; prepare complaint and feedback trend summaries.
Design Control Risk Management and Software Compliance Support
• Maintain and organize design and development records, including design reviews, verification and validation evidence, traceability matrices, and design change documentation.
• Support maintenance of risk management records and links among identified hazards, risk controls, verification evidence, and post-market feedback using knowledge of ISO 14971.
• Support review and organization of software lifecycle records using knowledge of IEC 62304 requirements, including software requirements, verification, configuration and change management, and problem resolution.
Quality System Support
• Support internal and external audits by retrieving records and tracking assigned actions; assist with nonconformance and corrective and preventive action (CAPA) documentation.
• Compile quality metrics, identify record gaps, and follow up on assigned actions. Escalate compliance concerns and decisions requiring approval to the Quality Manager.
Experience and Required Knowledge
• 3-5 years of experience in medical device quality or related quality systems work, including experience with 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 quality system requirements.
• Knowledge of medical device design control, ISO 14971 risk management, and IEC 62304 medical device software lifecycle requirements.
Education
Bachelor’s degree in engineering, biomedical engineering, life sciences, quality, or a related technical discipline, or an equivalent combination of relevant education and experience.
Preferred Qualifications
• 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.
Key Competencies and Work Environment
Strong attention to detail, organization, communication, and follow-through. Ability to manage multiple assignments, handle confidential information, and collaborate across technical and customer-facing teams in a medical device development and commercial environment.
