VideaHealth · 5 hours ago
Senior Quality Engineer
Greater Boston
Full-time
Hybrid
Mid, Senior Level
4+ years expVideaHealth is a cutting-edge AI-powered solution for dentistry, and they are seeking a Senior Quality Engineer to enhance their quality system execution and compliance. The role involves owning complaint handling, vigilance reporting, and ensuring compliance with global medical device regulations while collaborating with cross-functional teams.
BiotechnologyHealth CareSoftware
Responsibilities
Own complaint handling, vigilance reporting, nonconformance, CAPA, and post-market surveillance (PMS) processes end-to-end: intake, triage, investigation, root cause analysis (RCA) using structured methods (e.g., 5-Whys, fishbone, etc.), documentation, timely closure, and reporting/trending. Define and run quality KPIs and trending dashboards, identify signals, drive cross-functional follow-up actions, update DHF documents
Maintain and continuously improve the Quality Management System (QMS) and Security/Privacy Policies in compliance with ISO 13485, FDA 21 CFR Part 11/820, IEC 62304, EU MDR, HIPAA and other relevant regulations/standards: author/revise SOPs and Work Instructions (WIs), create practical templates/checklists, and ensure processes are followed
Partner with Director RAQA, Engineering, Product, and Clinical to ensure DHF documentation (design controls & risk management) meets regulatory requirements
Deliver effective training across the organization (role-based, practical, and measurable), and track training compliance
Drive audit readiness: prepare for internal and external audits, coordinate responses, and own remediation/closure of audit findings with objective evidence
Qualification
Required
BS in Engineering, Data Science or related analytical discipline
4–6 years of Quality experience in the medical device industry
Strong knowledge of ISO 13485, ISO 14971, IEC 62304 and FDA QSR/21 CFR Part 820; practical experience running DHF creation, complaints, NC/CAPA
Demonstrated ability to write and improve SOPs/WIs and create clear objective evidence for audits
Strong organizational and communication skills
Demonstrated ability to operate independently, prioritize competing needs, and drive closure across teams in a fast-paced environment
Preferred
Experience with SaMD/CDSS product software lifecycle quality (e.g., traceability, verification/validation evidence, risk controls)
Hands-on experience implementing or operating an eQMS (document/change control, training, CAPA/complaints, design & risk controls)
Experience supporting post-market surveillance trending and dashboards (e.g., Excel/Sheets, Tableau, or similar)
Knowledge of cybersecurity and electronic protected health information (ePHI) processes. This includes working knowledge of HITRUST, SOC2, HIPAA, and/or GDPR
CQE/CQA or Lean Six Sigma training/certification
Benefits
Competitive compensation
Benefits
Career advancement potential
Company
VideaHealth
VideaHealth is offers dentistAI’s software automatically detects pathologies in dental imaging, helping dentists avoid missing diseases.
51-200 employees
H1B Sponsorship
VideaHealth has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (2)
2023 (3)
2022 (3)
2021 (4)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$66.5MKey Investors
ThresholdSpark CapitalZetta Venture Partners
2025-01-28Series B· $40M
2022-03-31Series A· $20M
2020-01-01Seed
Leadership Team
Florian Hillen
CEO and Founder
Austen Asadorian
Chief Revenue Officer
Recent News
2026-01-07
Company data provided by crunchbase