Senior Quality Engineer

About Us:
VideaHealth is a cutting-edge AI-powered solution for dentistry, developed by a team of seasoned leaders, engineers, AI scientists, and clinicians spun out of MIT. We are on a mission to improve the lives of billions by transforming dentistry. Our product is already used by thousands of dental clinicians to improve the quality of care through faster diagnoses, increase operating efficiencies, and improved patient understanding.
Backed by leading venture capital firms and partnered with top dental organizations, we are rapidly expanding. At VideaHealth, you’ll join a collaborative, mission-driven team passionate about applying AI to real-world healthcare problems.

About this Position:
Senior Quality Engineer with 4–6 years of experience in the medical device industry and a BS in Engineering, Data Science, or related analytical discipline (mandatory). Software as a Medical Device (SaMD)/Clinical Decision Support Software (CDSS) product experience, eQMS implementation experience, and security/HIPAA familiarity is preferred.
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.

Don’t meet all the listed requirements? We still encourage you to apply! We are looking for the right teammate who is excited to contribute to our mission and are flexible on level of experience.

VideaHealth is committed to cultivating an equitable, inclusive, and supportive environment for all employees. We believe this environment creates a safe space for employees to share their experiences, brainstorm ideas, and grow their careers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.