Document Control Specialist

1 month ago

Hope, Arkansas, United States Orchestra BioMed Full time
About Orchestra BioMed

Orchestra BioMed is a pioneering biomedical innovation company that accelerates high-impact technologies to patients through strategic partnerships with leading medical device companies. Our vision is to revolutionize medical innovation by forging collaborative relationships with industry leaders to drive successful global commercialization of products we develop.

Our Mission

We are committed to applying our innovative business model to bring high-impact medical innovations to life and create extraordinary value for patients, care providers, partners, and stakeholders.

Job Summary

The QMS Document Control Specialist is responsible for managing and maintaining the company's Quality Management System documentation to ensure compliance with regulatory standards for medical devices. This role involves coordinating document revisions, approvals, distributions, and storage while ensuring all documentation meets internal and external audit requirements.

Key Responsibilities
  • Create, review, revise, and maintain QMS documents, including Standard Operating Procedures (SOPs), Work Instructions, Forms, and Records.
  • Ensure all documentation is controlled, accurate, current, and compliant with ISO 13485, FDA regulations, and other applicable standards.
  • Coordinate the approval process for new and revised documents, ensuring timely review and authorization.
Documentation Systems
  • Manage electronic document management systems (EDMS) to store and control QMS documents.
  • Implement and maintain document control procedures and processes.
  • Maintain and secure hard copy record files.
Audit and Compliance
  • Prepare for and support internal and external audits by ensuring documentation is readily available and compliant.
  • Address audit findings related to document control and implement corrective actions as necessary.
  • Support Lead auditor in conducting internal audits and documenting audit results.
Training and Support
  • Provide training and support to employees on document control processes and the use of the document management system and GDP requirements.
  • Assist with the development and delivery of QMS training materials.
  • Maintain and create job codes and training curriculum as needed.
Continuous Improvement
  • Identify opportunities for improvement in document control processes and implement best practices.
  • Collaborate with cross-functional teams to ensure alignment and compliance with QMS requirements.
  • Implement new eQMS modules as needed.
  • Assist in trending quality data as needed.

Requirements

  • Bachelor's degree in Quality Management, Life Sciences, Engineering, or a related field.
  • Certified Quality Auditor (CQA) or other relevant certifications strongly preferred.
  • Minimum of 3 years of experience in document control within the medical device industry or a regulated environment.
  • Understanding of document change management and FDA quality systems.
  • Knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
  • Strong attention to detail and organizational skills.
  • Proficiency in using electronic document management systems (EDMS) and Microsoft Office Suite.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Experience with quality management software (e.g., MasterControl, Veeva, or similar).
  • Familiarity with other regulatory standards (e.g., MDR, MDSAP).

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