This is a hands-on role that will own core Quality System execution and compliance —Complaint intake/investigations and Nonconformances, CAPA initiation and effectiveness, Post-Market Surveillance inputs and trending, SOP/WI continuous improvement and QMS training, and audit readiness and response. You will partner with Director of RA/QA to support VideaHealth’s medical device Agile SaMD design controls and patient/cybersecurity risk management, driving excellence in Design History File (DHF) creation and maintenance. The role also works cross-functionally with AI/ML and Software Engineering, Clinical, Product, and Customer Success.

The Sr. Quality Engineer will play a critical role in ensuring compliance with global medical device regulations and standards while supporting the safe and effective development and deployment of AI-powered dental solutions.

Who You Are (attributes, in priority order)

1. Analytical problem solver and process improver: Goes beyond “band aids”—evaluates complex inputs/data/systems to make sound decisions, maps the process end-to-end, pinpoints failure points, and redesigns the workflow so it stays fixed. → Whiteboards + sticky notes, flowcharts, pivot tables, Tableau dashboards; turns messy data into trends and a clear “here’s what changed” story.
2. Quality-first achiever: Runs a tight compliance operation and closes loops fast (without cutting corners). → Relentless about meeting regulations/expectations and closing work to completion, keeps DHFs audit-ready; writes CAPAs with measurable actions + effectiveness checks.
3. Influence without authority: An “extreme owner” of quality processes end-to-end who can get cross-functional teams to execute corrective actions on time—even when they’re busy. → Sets weekly accountability check-ins, assigns owners + dates, escalates at 48 hours past due, and walks into Eng/Clinical/CS meetings with the TLDR, exact ask, the evidence, and the deadline.
4. Collaborative partner: Makes compliance easy to follow by building tools and processes people actually use; enjoys building cross-functional relationships and mentoring others on compliance expectations. → Creates simple SOP/WI templates and checklists; runs efficient trainings with realistic examples.
5. Customer-oriented: Treats the field as a signal source and responds with clarity and urgency; balances business/patient/security risks. → Asks for the right artifacts (radiographs, logs, installation records, etc.), communicates investigation timelines, converts recurring issues into product/process improvements while keeping patient safety and data privacy/security front and center.

What You Will Do:

• 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.

Qualifications:

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.

Why Join Us:

• Help shape the future of dentistry by ensuring safe, compliant, and impactful AI medical devices.
• Work alongside a world-class team of engineers, clinicians, and business leaders committed to improving healthcare outcomes.
• Join a fast-growing, well-funded startup with strong backing and industry partnerships.
• Access mentorship and growth opportunities in a collaborative, inclusive environment.
• Competitive compensation, benefits, and career advancement potential.