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Document Control Specialist

1 month ago

Eden Prairie, Minnesota, United States Collagen Solutions Full time
Job Summary

The Document Control Coordinator will play a key role in developing, updating, and improving quality and regulatory affairs processes across multiple business units. This position will be responsible for implementing, maintaining, and training on SoftExpert software, as well as assisting with the global medical device strategy implementation.

Key Responsibilities
  • Develop and maintain proficiency in the SoftExpert System for archiving, managing, and accessing quality documents.
  • Manage document changes and activities using SoftExpert, serving as the primary point of contact.
  • Identify process improvement opportunities and provide recommendations for established workflows.
  • Design and create new forms required for use in the UK/EP, including scripting, workflows, and validation support.
  • Provide QMS-related training in the SoftExpert training module, including administration, setup, creation, and scheduling with employees.
  • Collaborate with Research & Development on the new product development module.
  • Work with production and shipping to prepare customer shipping documents.
  • Take ownership of responsibilities and drive change both locally and within the Collagen Solutions Network.
  • Maintain open communication with management, coworkers, customers, and counterpart staff in other sites.
  • Contribute to the implementation of new requirements and compliance with the quality management system.
  • Stay up-to-date with professional knowledge by attending educational workshops, reviewing publications, establishing personal networks, and benchmarking best practices.
  • Assume additional responsibilities as directed by management.
Requirements
  • 2 years of relevant experience.
  • Strong computer literacy and skills with Office 365.
  • Understanding of ISO 13485, GMP, and HACCP.
  • Excellent problem-solving skills, verbal and written communication skills, and attention to detail.
  • Ability to work as a team and manage multiple projects/tasks.
  • Proficiency in English.