Quality Assurance Lead: QMS, Audits & CAPA (Hybrid)

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

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