Quality Specialist

The Quality Specialist for Neuro One Medical Technologies Corporation will be responsible for administering the document control and training systems and supporting other quality functions within an electronic Quality Management System.

The Quality Specialist will also be responsible for compiling, analyzing, and reporting data for quality metrics.

The position will also support internal and external audits of the quality system and ensure compliance with 21 CFR 820, ISO 13485, and other applicable medical device standards and regulations.

• Coordinates and manages the document change control process, initiate document change requests, document distribution, review, and approval
• Ensures that the documents are controlled in compliance with regulations and standards
• Manages Quality Systems training program
• Manages employee QS onboarding, job‑specific training, and controlled document training
• Supports CAPA tracking, nonconformance documentation, and audit preparation
• Participate in ISO 13485 and MDSAP (US FDA 21 CFR 820) audits
• Coordinate/pilot meetings and training sessions with multiple participants both internal and external to the company
• Complete the periodic reviews of documents of external origin

• 1 to 5 years of experience in a regulated Quality Management System (e.g. 21 CFR 820, ISO 9001, ISO 13485, etc…)
• Proficient in MS Word, Excel, and Power Point
• Ability to read, write, and understand technical documents, such as standard operating procedures
• Attention to detail, organizational skills, and timeliness