Quality Assurance Associate

SleepRes™, Inc.

. Administer document control activities within the eQMS, including document creation, review, approval routing, release, revision, distribution, obsolescence, and archival .

Posted 10/20/2026full-timeFremont • California • United StatesMid-Level💰 $90,000 - $105,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in document control and quality management systems within the medical device industry, including compliance with FDA regulations and ISO standards. Proficient in training coordination, complaint handling, and supporting audits and CAPA processes.

Highest-signal resume keywords

Document Control ManagementQuality Management Systems (QMS)FDA Quality Management System Regulation (QMSR)ISO 13485 ComplianceTraining Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Document CreationDocument ReviewTraining Program AdministrationRisk ManagementDesign ControlVerification and Validation DocumentationComplaint HandlingCAPA DocumentationData MigrationConfiguration Changes

Soft Skills

Attention to DetailOrganizationCommunicationFollow-ThroughCollaboration

Tools & Technologies

Electronic Quality Management Systems (eQMS)Training MatricesControlled TemplatesTraceability MatricesSoftware Lifecycle Records

Industry Keywords

Medical Device QualityClass II Medical DevicesISO 14971IEC 62304CPAP DevicesRespiratory Therapy Devices

About the role

Key responsibilities & impact

Administer document control activities within the eQMS, including document creation, review, approval routing, release, revision, distribution, obsolescence, and archival
Maintain document numbering, revision history, effective dates, controlled templates, and applicable external standards within the eQMS
Review documents and change records for completeness, formatting, approvals, and training assignments; follow up on open actions
Administer the company training program, including training matrices, role-based curricula, onboarding, recurring training, and training triggered by controlled-document changes
Assign and track training, follow up on overdue assignments, and report completion status
Maintain training and competency records, including training-effectiveness evidence
Support day-to-day eQMS administration, user access, workflows, document and training modules, configuration changes, data migration, testing, and validation documentation
Log customer feedback and complaints, obtain missing information, and maintain traceability to devices, serial numbers, events, and supporting records
Coordinate complaint follow-up and support investigations, completeness checks, closure tracking, safety escalation, and trend summaries
Maintain design and development records, including design reviews, verification and validation evidence, traceability matrices, and design change documentation
Support risk management records and links among hazards, controls, verification evidence, and post-market feedback
Support organization of software lifecycle records under IEC 62304
Support internal and external audits, nonconformance and CAPA documentation, quality metrics, record-gap identification, and action follow-up
Escalate compliance concerns and approval decisions to the Quality Manager

Requirements

What you’ll need

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
Bachelor’s degree in engineering, biomedical engineering, life sciences, quality, or a related technical discipline, or an equivalent combination of relevant education and experience
Experience with CPAP or other respiratory therapy devices, connected hardware/software medical devices, or eQMS implementation preferred
Experience supporting complaint handling, audits, CAPA, or software verification and validation documentation preferred
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