Quality Specialist

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC); Eden Prairie (MN); On-site; USD 55,000 - 75,000; Full time

Job summary

NeuroOne Medical Technologies Corporation in Eden Prairie, MN, is seeking a Quality Specialist to administer document control and training within our electronic Quality Management System, and to support other quality functions.

You will compile, analyze, and report quality metrics, and assist with internal and external audits to ensure compliance with 21 CFR 820, ISO 13485, and related medical device standards. Help maintain CAPA tracking and audit readiness.

Qualifications

• 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 PowerPoint
• Ability to read, write, and understand technical documents, such as standard operating procedures
• Attention to detail, organizational skills, and timeliness

Responsibilities

• 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

Skills

Attention to detail

Organizational skills

Timeliness

Tools

MS Word

Excel

PowerPoint

Job description

The Quality Specialist for NeuroOne 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.

Key Responsibilities:

• 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

Qualifications:

• 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 PowerPoint
• Ability to read, write, and understand technical documents, such as standard operating procedures
• Attention to detail, organizational skills, and timeliness