Quality Assurance Officer

Position Summary 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. We welcome candidates who are comfortable experimenting with AI-assisted workflows and applying them responsibly in a regulated environment. Responsibilities QMS Documentation & Change Control Maintain and update QMS documentation Initiate, evaluate, and manage engineering and document change requests Develop training materials and support quality training sessions Maintain and assist with recurring QMS activities in a timely manner Audits & Supplier Quality Support internal and external quality and regulatory audits Assist with supplier evaluations and audits Quality Control & CAPA Perform product quality control and inspections Address non-conformities and contribute to corrective and preventive actions (CAPA) Support ongoing revision and improvement of the QMS AI-Augmented Development Use AI-assisted tools (e.g., LLM-powered coding assistants, automated documentation) to accelerate development tasks Apply AI tools responsibly within PASCALL's regulated development environment Qualifications Education Bachelor's degree in Engineering, Life Sciences, or related field ISO 13485 and/or ISO 9001 training certificate (preferred, not mandatory) Experience and Skills 2+ years of relevant industry experience Exceptional attention to detail, strong organizational and analytical skills Excellent written and verbal communication Proactive and able to work independently and collaboratively in a fast-paced environment Comfort using AI-assisted tools (e.g., Claude / Claude Code, ChatGPT) for documentation and quality analysis Technical Background Knowledge of quality management system principles and regulations (e.g., FDA QMSR, ISO 13485, ISO 9001) Experience in a regulated medical device or life sciences environment 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 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. We are a small team solving problems without textbook answers, and we give team members real ownership of their work and contributions. Our mission is to bring personalized, science-based anesthesia care to all patients. Work Location: Hybrid remote in Cambridge, MA 02139 #J-18808-Ljbffr Pascall Systems, Inc.