What are the responsibilities and job description for the Document Control Coordinator position at Incipio Devices?
Job Summary
We are seeking a highly organized and detail-oriented Document Control Coordinator to join our dynamic team. In this vital role, you will oversee the management, review, and distribution of critical documentation across various departments, ensuring compliance with industry standards and regulatory requirements. Your proactive approach will support seamless project workflows, uphold quality management systems, and maintain rigorous document accuracy. This position offers an exciting opportunity to contribute to a fast-paced environment where precision and efficiency are paramount.
Duties
- Develop, implement, and maintain document control procedures aligned with ISO 13485, ISO 9001, FDA regulations, and pharmaceutical regulatory compliance standards.
- Manage document workflows using document management systems such as SharePoint and other project management software to ensure timely review, approval, and distribution.
- Organize, file, and archive technical documents, quality records, and regulatory submissions in accordance with company policies and legal requirements.
- Review documents for accuracy, completeness, and compliance; proofread technical writing to ensure clarity and consistency.
- Facilitate cross-functional communication by coordinating document review processes among engineering, quality assurance, regulatory teams, and external partners.
- Maintain meticulous records of document revisions, approvals, and distribution logs to support audit readiness and regulatory inspections.
- Support data entry and data management efforts related to document control activities while ensuring data integrity and confidentiality.
Skills
- Strong knowledge of ISO 13485, ISO 9001 standards, FDA regulations, and pharmaceutical regulatory compliance.
- Proven experience with document control within the engineering or manufacturing industry.
- Proficiency in SharePoint, Microsoft Office Suite (Word, Excel, PowerPoint), and project management software for document workflow management.
- Excellent organizational skills with the ability to manage multiple projects simultaneously while maintaining attention to detail.
- Effective communication skills for collaborating across departments and ensuring document compliance management.
- Familiarity with records management principles, filing systems, proofreading techniques, and technical writing best practices.
- Ability to adapt quickly to changing priorities in a fast-paced environment while maintaining high standards of accuracy.
Minimum Qualifications
- -3 years experience in a medical manufacturing environment preferred, but not
- required
- -Basic understanding of document control systems
- -Communication skills: ability to positively interact with customers, suppliers, and
- employees
Join us as a Document Control Coordinator to play a crucial role in safeguarding our quality standards while supporting innovative projects that make a difference!
Pay: $20.00 - $25.00 per hour
Expected hours: 40.0 per week
Benefits:
- 401(k)
- 401(k) matching
- AD&D insurance
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Work Location: In person
Salary : $20 - $25