As PASCALL scales its FDA-cleared EEG platform and expands the quality function beyond a single QA resource, we need a Quality Officer to own day-to-day execution of the Quality Management System (QMS), keeping documentation, audits, and change control running reliably as the company grows. This person will work closely with the Head of Quality on QMS maintenance, improvement and support, as well as assist with internal and external audits. They'll also contribute to supplier quality oversight and CAPA execution, giving them real ownership over how quality operates day-to-day.

In addition, this individual will collaborate with various engineering teams to support the documentation of design improvements/changes and process documentation changes, adhering to QMS, regulatory, and standard requirements as applicable. PASCALL actively uses agentic AI tools to accelerate development, documentation, and quality operations. QMS Documentation & Change Control Develop training materials and support quality training sessions Audits & Supplier Quality Support internal and external quality and regulatory audits Quality Control & CAPA Perform product quality control and inspections LLM-powered coding assistants, automated documentation)



to accelerate development tasks Bachelor's degree in Engineering, Life Sciences, or related field ISO 13485 and/or ISO 9001 training certificate (preferred, not mandatory) Claude / Claude Code, ChatGPT) for documentation and quality analysis Technical Background Knowledge of quality management system principles and regulations (e.g., Experience in a regulated medical device or life sciences setting 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 system in 2022, with a recent clearance in Aug 2026. We are now building the next generation of EEG-based brain state algorithms to improve anesthesia care and patient outcomes worldwide.

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

Work Location: Hybrid remote in Cambridge, MA 02139 #

📌 Quality Assurance Officer (British Columbia)
🏢 Pascall Systems
📍 British Columbia