Document Control Administrator

TL;DR

Document Control Administrator: Supporting documentation administration within the Quality function for medical device manufacturing with an accent on GMP compliance and QMS maintenance. Focus on managing change records, controlling document distribution, and ensuring adherence to FDA regulations and internal quality standards.

Location: Must be based in Plymouth, MN

Salary: $24.59–$36.07 per hour

Company

hirify.global is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance the lives of patients worldwide.

What you will do

• Provide administrative support for change record implementation following standard operating procedures.
• Control the distribution, retrieval, and access of controlled documents and electronic files.
• Compile and review quality records, reports, and Device History Records (DHR) ensuring Good Documentation Practices (GDP).
• Assist the Quality department during audits and provide guidance to other departments.
• Train personnel on proper system utilization and documentation processes.
• Perform annual record disposition reviews and manage on-site and off-site documentation.

Requirements

• Must be based in or able to work in Plymouth, MN
• 3-4 years of relevant experience in administration or quality documentation.
• Proficient understanding of Electronic Documentation Systems and Quality Management Systems (ISO9001, ISO13485, FDA 21CFR Part 820).
• Strong organizational skills with the ability to prioritize and meet deadlines.
• Effective communication skills and attention to detail.
• General computer operation skills including Microsoft Teams, Excel, and Word.

Culture & Benefits

• Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, and life insurance.
• 401(k) plan with company matching contributions.
• 80 hours of company-designated holidays per year plus annual paid time off.
• Cash-based incentive program supporting a pay-for-performance philosophy.
• Parental leave available after one year of service.
• Opportunities for on-the-job training and professional development.