Document Control Administrator (Medtech)

TL;DR

Document Control Administrator (Medtech): Supporting documentation administration within the Quality function with an accent on GMP adherence and Quality system guidelines. Focus on controlling distribution of controlled documents, reviewing Device History Records, and assisting during audits.

Location: Onsite in Plymouth, MN

Salary: $20.23–$29.67 per hour

Company

hirify.global is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs and high-end niche batteries for specialized applications.

What you will do

• Support documentation administration within the Quality function adhering to GMP and Quality system guidelines.
• Manage distribution, retrieval, and access to on-site and off-site electronic and physical records.
• Review Device History Records (DHR) in accordance with established procedures and Good Documentation Practices (GDP).
• Provide administrator support for change record implementation and notify functions of external document changes.
• Assist the Quality department during audits and provide data analysis to other departments.
• Conduct annual record disposition reviews and compile quality reports.

Requirements

• High school diploma or equivalent.
• 2-3 years of experience in administration activities.
• Working knowledge of Electronic documentation systems.
• Understanding of Quality Management Systems (ISO9001, ISO13485, FDA 21CFR Part 820).
• Must be based in Plymouth, MN.

Culture & Benefits

• Comprehensive benefits package including medical, dental, vision, disability, and life insurance.
• 401(k) plan with company matching contributions.
• Paid time off and 10 company-designated holidays per year.
• Incentive program supporting a pay-for-performance philosophy.
• Parental leave available after one year of service.