Document Control Specialist
Job Type
Full-time
Description


SetPoint Medical is seeking an experienced, high caliber Document Control Specialist to own the process for ensuring all company-wide controlled documentation and records in the quality management system (QMS) meet regulatory and quality compliance standards of a medical device company and to facilitate training on policies and procedures. The successful candidate must be an organized, self-motivated individual with the ability to adjust to workloads based upon the changing priorities that come with working in a fast-paced small company environment.



Requirements
  • Ensure documents and records meet company and regulatory standards 
  • Manage, organize, and maintain all company-controlled documentation and records
  • Create and/or update Standard Operating Procedures (SOPs), Work Instructions, and Forms used in the Document Management, Change Management, and Records Management processes
  • Collaborate with cross-functional departments to ensure timely completion of document change requests and associated impact assessments
  • Support audits (internal and external) to verify that regulatory and company quality requirements have been met
  • Manage paper and electronic files in the company’s QMS document control system in accordance with document lifecycle policies and procedures
  • Manage archiving all Device History Records (DHR) and facility records
  • Provide expertise and problem resolution to company team members when issues arise
  • Identify areas for improvement within document, change, records, and training management processes and develop and execute improvement plans

Minimum Qualifications:

  • Education or experience in life science or technical writing, English, or communications field preferred 
  • 4+ years of experience in a pharmaceutical, biotechnical, or medical device document control environment (experience with active implantable devices preferred)
  • 3+ years in the management of QMS document control systems
  • Experience and proficiency with the Microsoft Office suite of tools including Word, Outlook, PowerPoint, Excel, Visio, and Adobe Acrobat Pro
  • Understanding of the fundamentals of documentation management in a medical device company
  • Working knowledge of quality systems and regulatory requirements (21 CFR 11, 21 CFR 820 and AIMDD)
  • Knowledge of FDA Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP)

Skills and Abilities:

  • Attention to detail
  • Excellent verbal and written communication skills 
  • Ability to learn and understand technical aspects of the electronic document management (eDM) solution (e.g. ability to troubleshoot issues, extract data)
  • Demonstrated ability to work cross-functionally, especially with product development, quality, and manufacturing
  • Demonstrated ability to thrive in a fast-paced and dynamic environment
  • Demonstrated initiative, independence, and leadership

Travel Requirements:

Up to 5%


Location:

Company Headquarters in Valencia, CA


Company Description:

SetPoint Medical is an early stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.