Senior Document Control Coordinator (Medical Devices)

Location: Plymouth, MN, United States; onsite

Salary: $24.59–$36.07 per hour

Company

hirify.global develops and manufactures products subject to medical device quality and regulatory requirements.

What you will do

• Support documentation administration within the Quality function under defined procedures and with minimal supervision.
• Administer change record implementation and control the distribution, retrieval, access, and storage of controlled documents and records.
• Notify relevant functions about changes to local external documents and perform annual record disposition reviews.
• Compile and complete quality records and documentation using Good Documentation Practices, and review Device History Records according to applicable procedures.
• Support the Quality department during audits and provide guidance and analysis to other departments.
• Train personnel on the proper use of documentation systems and processes, identify quality non-conformances, and contribute to corrective and preventive actions and process improvements.

Requirements

• Diploma or equivalent in administration preferred.
• 4+ years of experience, with expertise developed through on-the-job training and job experience.
• Leadership skills, including providing subject-matter guidance to junior team members and other users.
• Advanced oral and written communication skills for communicating complex, detailed information.
• Strong organizational skills, including time management, prioritization, and meeting deadlines.
• General computer operation skills, including Microsoft Teams, Excel, and Word.
• Strong attention to detail when reviewing and preparing documents, plus problem-solving skills for identifying creative solutions to atypical problems.
• Proficient understanding of electronic documentation systems, Quality Management Systems such as ISO 9001, ISO 13485, and FDA 21 CFR Part 820, and office management and administration.
• Ability to follow company policies, safety and quality requirements, QMS and EMS requirements, FDA regulations, operating procedures, GMP, GDP, and other applicable regulatory requirements.

Culture & Benefits

• Values-based culture focused on customer success, innovation, collaboration, inclusion, candor, and integrity.
• On-the-job training, cross-training, and classroom instruction to expand skills.
• Medical, dental, vision, disability, life insurance, and adoption benefits with immediate eligibility.
• Parental leave after one year and optional supplemental life, critical illness, hospital indemnity, and accident insurance programs.
• Immediate eligibility for a 401(k) plan with company matching contributions, plus 80 hours of company-designated holidays and annual paid time off.
• Additional compensation programs may include cash-based incentives, overtime pay, shift differentials, and call-in pay where applicable.