Document Control Coordinator (Medical Devices)

Location: Plymouth, MN, United States; onsite.

Salary: $20.23–$29.67 per hour.

Company

hirify.global develops and manufactures medical device products with a focus on customer success, innovation, collaboration, inclusion, candor, and integrity.

What you will do

• Support documentation administration within the Quality function under GMP, GDP, QMS, FDA, safety, and regulatory requirements.
• Administer change records and control the distribution, retrieval, access, and disposition of controlled documents and records.
• Compile quality records and reports and review Device History Records according to applicable procedures.
• Notify functions about changes to local external documents and support on-site and off-site records management.
• Assist with Quality audits, provide guidance and analysis to other departments, and train personnel on systems and processes.
• Identify and escalate quality non-conformances and contribute to corrective and preventive actions, process improvements, quality KPIs, and the site’s 5 Sigma journey.

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 organization, time management, prioritization, and deadline-management skills.
• General computer skills, including Microsoft Teams, Excel, and Word.
• Strong attention to detail and problem-solving ability, including finding 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.

Culture & Benefits

• On-the-job training, cross-training, and classroom instruction support skill development.
• Benefits are available immediately and include medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave is available after one year.
• Employees are immediately eligible for a 401(k) with company matching contributions.
• Includes 80 hours of company-designated holidays, annual paid time off, overtime pay, shift differentials, and call-in pay when applicable.
• U.S. applicants are covered by equal opportunity employment practices; veterans and individuals with disabilities are encouraged to apply.