Head of Quality

Head of Quality

Position Summary

PASCALL is an early-stage medical device company developing an EEG-based brain state monitoring system for personalized anesthesia monitoring. We hold ISO 13485 certification and FDA 510(k) clearance for our first platform device and are actively expanding our product and regulatory scope.

The Head of Quality will report to the COO and work closely with engineers across hardware, software, algorithm, and clinical teams. You will be responsible for the day-to-day execution and continuous improvement of PASCALL’s QMS — including document control, risk management support, and QMSR transition — while also taking a forward-looking role in how PASCALL uses AI tools to make quality processes smarter, faster, and more accessible to the whole team. This is an opportunity for someone who wants to build a quality function, not just maintain one.

PASCALL actively uses agentic AI tools to accelerate development, documentation, and quality systems work. We welcome candidates who are comfortable experimenting with AI-assisted workflows and applying them responsibly in a regulated environment.

Responsibilities

QMS Ownership and Document Control

• Own PASCALL’s QMS, hosted in Atlassian Confluence, and serve as the primary point of accountability for document quality, consistency, and compliance
• Draft, revise, and maintain controlled documents — SOPs, Work Instructions, and Forms (L2/L3/L4) — in accordance with ISO 13485:2016 and 21 CFR Part 820
• Manage document change requests, impact analyses, and review and approval workflows
• Maintain cross-document traceability and resolve reference conflicts, version issues, and hierarchy inconsistencies
• Support cross-document consistency across the nonconformance, investigation, and CAPA process chain

Risk Management and Regulatory Compliance

• Develop and maintain risk analysis processes; support risk management documentation review in accordance with ISO 14971 and IEC 62366
• Lead PASCALL’s ongoing QMS-to-QMSR transition, including terminology updates, SOP and WI alignment, and gap analysis
• Conduct internal audits and support external audits and ISO recertification activities
• Monitor the regulatory landscape and flag emerging compliance requirements relevant to PASCALL’s device classification and development stage

AI-Augmented Quality Systems

• Identify and implement opportunities to use AI tools to improve QMS processes — including automated gap analysis, document review assistance, and compliance monitoring
• Develop and maintain a PASCALL Quality AI assistant to help employees navigate QMS documentation and FDA/ISO regulatory requirements
• Apply AI tooling responsibly within PASCALL’s regulated development environment, with appropriate validation and documentation

Qualifications

Education

• Bachelor’s degree in Engineering, Life Sciences, or a related field

Experience and Skills

• 3+ years of hands-on QMS experience in a medical device context — ISO 13485:2016, 21 CFR Part 820, and ISO 14971 working knowledge required
• Demonstrated experience drafting and revising controlled documents (SOPs, WIs, forms) at the section level
• Experience conducting or supporting internal audits; ISO recertification experience a plus
• Self-directed and comfortable operating with limited oversight — able to prioritize and execute against a defined scope in a small team environment
• Clear written communication; able to work asynchronously across a distributed team

Technical Background (Preferred)

• Hands-on experience with design controls, risk management documentation, or V&V in a D&D environment
• Familiarity with QSR Modernization Rule (21 CFR 820.198) and QMSR transition requirements
• Experience with Atlassian Confluence as a QMS platform; ADF editing experience strongly preferred
• CQE, RAC, ISO 13485 Lead Auditor, or equivalent certification
• Prior experience in an early-stage or startup medtech environment
• Comfort using AI-assisted tools (e.g., Claude / Claude Code, ChatGPT, Cursor) for documentation, analysis, or quality workflows

About PASCALL Systems

PASCALL is a Cambridge-based medical device company focused on advancing neuroscience-based personalized anesthesia monitoring. Our team includes leading academic and clinical experts from MIT, Harvard, Stanford, and Massachusetts General Hospital.

We achieved ISO 13485 certification for medical device design and development and received FDA 510(k) clearance for our first platform device in 2022. We are now building the next generation of EEG-based brain state algorithms to improve anesthesia care and patient outcomes worldwide.

Our vision is to bring personalized, science-based anesthesia care to all patients.

How to Apply

Only candidates who submit a Cover Letter addressing all of the following questions will be considered:

• What excites you about this position and PASCALL’s mission, and what draws you to a quality role at an early-stage medical device company?
• Describe a quality project you’re proud of — what was the context, what did you own, and what was the outcome?
• PASCALL has an active vision for using AI tools to improve QMS processes and compliance. Describe how you’ve used technology — including AI tools — to improve quality or documentation workflows, and how you’d approach applying them in a regulated environment.

Details

Pay: $90,000 – $115,000 per year

Work Location: In person — Cambridge, MA

Job Type: Full-time

Pay: $90,000.00 - $125,000.00 per hour

Work Location: In person