Document Control Specialist

3 days ago


Reston, Virginia, United States Terumo Medical Corporation Full time
Job Summary

This Document Control Specialist position is a critical role in maintaining control of all quality documentation. The successful candidate will be responsible for ensuring accuracy, completeness, and compliance with established procedures and policies.

The ideal candidate will have proven experience in document control within a regulated environment, preferably in a medical device company. They will possess strong problem-solving skills, the ability to adapt to changing requirements, and effective interpersonal skills for working with various departments and stakeholders.

Key Responsibilities
  • Maintain and oversee all quality documentation to ensure accuracy, completeness, and compliance with established procedures and policies.
  • Follow and enforce document control procedures in alignment with quality system good manufacturing practices and other applicable regulations.
  • Accomplish daily tasks with minimal supervision, demonstrating a high degree of self-management and accountability.
  • Work closely with all departments to ensure a compliant document control program is maintained.
  • Educate and train team members and other employees on document control processes and the use of the document management system software.
  • Regularly update and organize controlled documents in collaboration with subject matter experts.
Requirements

The successful candidate will have:

  • Proven experience in document control within a regulated environment, preferably in a medical device company.
  • Strong problem-solving skills and the ability to adapt to changing requirements.
  • Effective interpersonal skills for working with various departments and stakeholders.
  • Detail-oriented with a focus on accuracy and compliance.
  • Ability to clearly communicate, both verbal and written with all levels of organization.
  • Proficiency in document management system software.
  • Strong computer knowledge (MS Office) and technical writing skills.
  • Demonstrated initiative and ability to handle multiple tasks.
  • Good theoretical knowledge with ISO standards (ISO regulatory requirements, and related labeling regulations (21 CFR 820).
Education and Experience

The ideal candidate will have:

  • An associate degree, 4-year degree preferred.
  • 3 years of experience in a manufacturing environment required.
  • Experience in a document control environment preferred.
  • Experience in training and mentoring others in document control processes.
  • Experience working in the medical or other highly regulated industry, specifically ISO 13485 and FDA CFR820.


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