Document Control & Compliance Specialist (eQMS)

Nacs,-Inc.; Ham Lake (MN); On-site; USD 41,328 - 49,593; Full time

Job summary

NACS Ascential Medical & Life Sciences in Ham Lake, MN reviews and maintains document control with ISO 13485 and FDA 21 CFR guidelines. The role coordinates training programs, handles logbooks, and supports internal and external audits while ensuring timely responses to documentation requests.

Ideal candidates have 2-5 years in a regulated environment, familiarity with eQMS systems, and knowledge of FDA/ISO requirements.

Qualifications

• Experience with electronic document control and training system.
• Experience in the regulated industry.
• Working knowledge of FDA (21 CFR parts 4, 11, 210, 211, & 820), GMP, and ISO 13485.
• Experience working with eQMS systems.

Responsibilities

• Maintains document compliance with ISO 13485 and FDA 21 CFR guidelines.
• Manages training set-up and record retention.
• Administers the annual training review process to ensure employee training records remain current.
• Coordinates controlled documentation within the company.
• Performs the Document Control function within the eQMS system.
• Supports user requests for documentation and trains users in eQMS system.
• Supports change management and ensures accurate document change requests are completed.
• Supports implementation of documentation, procedures, and specifications.
• Ensures compliance to document control, regulatory and training requirements.
• Assist with redlines reviews and creation of new documents.
• Verifies new and revised documents meet formatting and template standards.
• Track and maintain distribution of hard copies and logbooks.
• Assist in supporting external audits and audits responses.
• Investigates corrective actions related to Document Control activities.
• Track performance metrics for Management Review.

Skills

Electronic document control

Training system

eQMS

Tools

eQMS software

Job description

NACS Ascential Medical & Life Sciences in Ham Lake, MN reviews and maintains document control with ISO 13485 and FDA 21 CFR guidelines. The role coordinates training programs, handles logbooks, and supports internal and external audits while ensuring timely responses to documentation requests.

Ideal candidates have 2-5 years in a regulated environment, familiarity with eQMS systems, and knowledge of FDA/ISO requirements.