{"id":2965867,"url":"https://alion.io/job/sleepres-quality-assurance-associate","title":"Quality Assurance Associate","company":{"id":4399586,"name":"SleepRes","domain":"sleepres.com","url":"https://alion.io/company/sleepres","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Breezy","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Francisco, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":74000,"max_usd":139000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":295},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-20T20:05:10Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-22T09:00:36Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"About SleepRes\nSleepRes 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.\nPosition Summary\nThe 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.\nThe 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.\nResponsibilities\nDocument Control\nAdminister 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.\nMaintain 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.\nReview documents and change records for completeness, formatting, required approvals, and associated training assignments; follow up on open actions.\nTraining Program Management\nAdminister 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.\nSupport onboarding and role changes by ensuring employees are assigned the appropriate eQMS training curricula based on job responsibilities.\nAssign and track training in the eQMS, follow up on overdue assignments, and report completion status to the Quality Manager and department leads.\nMaintain training and competency records, including evidence of training effectiveness where required by procedures.\neQMS Administration\nSupport eQMS day-to-day administration, including approved user access, workflows, document and training modules, and user assistance.\nSupport controlled configuration changes, data migration, testing, and validation documentation under approved plans; escalate system and data integrity issues.\nFeedback and Complaint Support\nLog customer feedback and complaints, obtain missing information, and maintain traceability to the device, serial number, event, and supporting records.\nCoordinate follow-up with Customer Care, Engineering, and Operations; support complaint investigations, record completeness checks, and tracking to closure.\nPromptly escalate potential safety issues and time-sensitive events to Quality and Regulatory for evaluation and reporting decisions; prepare complaint and feedback trend summaries.\nDesign Control Risk Management and Software Compliance Support\nMaintain and organize design and development records, including design reviews, verification and validation evidence, traceability matrices, and design change documentation.\nSupport maintenance of risk management records and links among identified hazards, risk controls, verification evidence, and post-market feedback using knowledge of ISO 14971.\nSupport review and organization of software lifecycle records using knowledge of IEC 62304 requirements, including software requirements, verification, configuration and change management, and problem resolution.\nQuality System Support\nSupport internal and external audits by retrieving records and tracking assigned actions; assist with nonconformance and corrective and preventive action (CAPA) documentation.\nCompile quality metrics, identify record gaps, and follow up on assigned actions. Escalate compliance concerns and decisions requiring approval to the Quality Manager.\nExperience and Required Knowledge\n3-5 years of experience in medical device quality or related quality systems work, including experience with Class II medical devices.\nPractical experience with document control, training coordination, and electronic document or quality management systems.\nWorking knowledge of FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, and ISO 13485 quality system requirements.\nKnowledge of medical device design control, ISO 14971 risk management, and IEC 62304 medical device software lifecycle requirements.\nEducation\nBachelor’s degree in engineering, biomedical engineering, life sciences, quality, or a related technical discipline, or an equivalent combination of relevant education and experience.\nPreferred Qualifications\nExperience with CPAP or other respiratory therapy devices, connected hardware/software medical devices, or eQMS implementation.\nExperience supporting complaint handling, audits, CAPA, or software verification and validation documentation.\nKey Competencies and Work Environment\nStrong 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.","description_format":"text","description_chars":5438,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Respiratory & Sleep Devices","Medical Education & Training"],"lifecycle":[{"event":"open","at":"2026-10-21T00:04:15Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":7,"reasons":["conf:0","win:early"],"computed_at":"2026-10-22T06:10:10Z"},"pay":null,"html_url":"https://alion.io/job/sleepres-quality-assurance-associate","json_url":"https://alion.io/job/sleepres-quality-assurance-associate.json","meta":{"generated_at":"2026-10-22T10:46:29Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":8172,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4399586},"rest":"https://alion.io/mcp/rest/get_company?id=4399586"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsleepres-quality-assurance-associate"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fsleepres-quality-assurance-associate"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fsleepres-quality-assurance-associate"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/sleepres-quality-assurance-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsleepres-quality-assurance-associate"}]}