Quality Assurance Officer

Pascall Systems, Inc.; Cambridge (MA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

PASCALL Systems, Inc. is a Cambridge-based medical device company focused on advancing neuroscience-based personalized anesthesia monitoring.

The Quality Officer will own the day-to-day execution of the Quality Management System, keeping documentation, audits, and change control running reliably as the company grows. The role collaborates with the Head of Quality and engineering teams to support design documentation, supplier quality oversight, CAPA execution, AI-assisted workflows, and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field is required.
• ISO 13485 and/or ISO 9001 training certificate is preferred but not mandatory.
• 2+ years of relevant industry experience desired.

Responsibilities

• 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.
• Support internal and external quality and regulatory audits.
• Assist with supplier evaluations and audits.
• Perform product quality control and inspections.
• Address non-conformities and contribute to CAPA.
• Support ongoing revision and improvement of the QMS.
• Use AI-assisted tools to accelerate development tasks.
• Apply AI tools responsibly within regulated development environment.

Skills

Attention to detail

Organizational skills

Analytical skills

Written communication

Verbal communication

Independent work

Team collaboration

AI tools

Education

Bachelor's degree in Engineering, Life Sciences, or related field

ISO 13485 and/or ISO 9001 training certificate

Job description

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