Document Control Specialist in Chanhassen, Minnesota at MedSource Labs LLC

MedSource Labs is a leading developer and supplier of innovative, high-quality medical products focused on improving patient outcomes across a wide range of healthcare settings. Since 2002, the company has delivered reliable, cost-effective solutions to emergency medical providers, hospitals, surgical centers, veterinarians, dental professionals, and government agencies. Headquartered in Chanhassen, Minnesota, MedSource Labs combines advanced technology with deep industry expertise to meet—and exceed—the evolving needs of the healthcare industry.

The company is driven by a strong commitment to its people and a collaborative, inclusive culture. MedSource Labs values diverse perspectives, recognizing that they fuel innovation and strengthen its ability to compete and grow. By fostering an environment of empowerment, teamwork, and continuous development, the organization enables its employees to contribute meaningfully to its mission of advancing healthcare and improving both clinical outcomes and operational efficiency.

We are seeking a Document Control Specialist to support our Quality Team. The Document Control Specialist is responsible for ensuring the accuracy, accessibility, and correct filing of all documentation within our organization. The Document Control Specialist will collaborate closely with all departments to establish and maintain efficient document control processes in adherence to regulatory and internal requirements.

Duties and Responsibilities:

• Works with all departments to ensure compliance with regulatory standards, third-party certification standards, and internal policies.
• Data entry, data management, and report generation.
• Document Management:
• • Transitioning all paper files into the eQMS.
  • Reviewing documents and records.
  • Oversee the review, approval, and maintenance of controlled documents, including but not limited to standard operating procedures, work instructions, guidance documents, specifications, and forms.
  • Follow internal guidelines on the identification of documentation within the eQMS.
• Document Retrieval and Distribution:
• • Develop and maintain documentation within our electronic quality management system (eQMS) to ensure efficient document retrieval and distribution.
  • Coordinate document retrieval requests from internal stakeholders and provide support for document-related inquiries.
• Continuous Improvement:
• • Identify opportunities for process improvements within the document control function and contribute to the implementation of best practices.
  • Participate in cross-functional teams and initiatives aimed at enhancing document management processes and ensuring organizational efficiency.
  • Perform inspections of incoming product shipments and the approval of inspection documentation as needed.
• Notifies supervisor of issues that could affect the product, processes and/or any relationship with customers.

Qualifications:

• High School Diploma or Equivalent Experience
• 1-3 years’ experience preferred.
• Basic understanding of Excel, Microsoft Outlook, and PowerPoint. Strong written and verbal communication skills with a focus on attention to detail.
• Knowledge of the medical device industry and the FDA and ISO regulatory requirements preferred.
• Strong understanding of regulatory requirements governing document control, including FDA regulations (21 CFR Part 820) and ISO standards (ISO 13485) preferred.
• Prior experience in document control within the medical device or pharmaceutical industry is highly desirable.
• Proficiency in document management systems and software tools
• Excellent organizational skills with a keen eye for detail and accuracy.
• Ability to lift and transfer up to 25 lbs.