Document Control Manager

We are looking for a Document Control Manager to join our team and experience what being "The Best Virtual Care Solution" means. Some of the perks that our employees enjoy include:

• Growth possibilities
• Competitive Health & Welfare Benefits
• Company paid Basic Life insurance: $50,000 for each employee
• Company paid Long-Term Disability benefits
• 401k plan with company match
• Employee Appreciation Days
• Employee Wellness Events
• Competitive pay

Other benefit offering includes:

• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Job Summary:

The Document Control Manager is responsible for managing GlobalMed’s Document Control System and Training Program ensuring compliance to all quality objectives and regulatory requirements. The manager is responsible for providing guidance regarding compliance related activities, communicating best practices to ensure consistency of compliance activities, and providing support during internal and external audits. Maintains the electronic and physical document directories of all documents to be retained in the document control center.

Duties & Responsibilities:

• Supervises employees, tasks and duties related to the Document Management and Training Systems.
• Maintain document control database of all filed documentation and records.
• Manage archival activities for controlled documents and validation of files to meet requirements of 21 CFR part 820 and ISO 13485 by ensuring standard practices and procedures are followed when analyzing data and content.
• Responsible for issuing controlled documents and record retention in accordance with internal polices and regulatory requirements.
• Manages the periodic review process of documents.
• Assist with processing of engineering change requests, new and versioning document changes requests, administrative changes, document retirement, and deviations utilizing change control systems, and procedures.
• Manage the training system to ensure that training records are maintained in accordance with regulatory and site training requirements.
• Assist with documentation and closure of non-conformance, corrective action, and preventive action events.
• Assist with creating quality documents such as work instructions, standard operating. procedures, and design control documents in a controlled environment.
• Provide support during internal audits, client audits and regulatory inspections.
• Monitor and report on all Quality Management System activities.
• Performs other related duties as assigned.

Qualifications:

• Bachelor's Degree (BA) from four-year college or university, or five (5) years of related experience and/or training, or equivalent combination of education and experience.
• At least five years of experience in a Quality Assurance, Compliance or Auditing role