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Document Control Specialist

VentriFlo Inc Pelham, NH

  • Posted: over a month ago
  • Full-Time
Job Description

Job Description

The Document Control Specialist role has primary responsibility for supporting and managing the Document Control System assisting with development and implementation of standard operating procedures in compliance with applicable FDA, ISO-13485, CE and other regulatory certification requirements as well as with internal policies and objectives.

Job Functions (Essential):

  • Responsible for supporting the execution of document control activities to ensure compliance to applicable medical device Quality Management System (QMS) policies, procedures and executed forms (e.g. design, development, production, labeling and distribution records) and associated regulations or standards (e.g. US QSR, ISO 13485, etc)
  • Support execution of control and traceability for QMS documents through maintenance of logs, databases and catalogues in compliance with applicable QMS and regulatory requirements (e.g. ISO 13485 and FDA)
  • Support periodic review/inspection assessments of QMS documentation (e.g. executed design, development, production and distribution forms and templates for compliance to QMS policies and procedures, ISO 13485, US 21CFR11, and US 21CFR820 requirements)
  • Prepares status reports, assigns, and monitors document and part numbers
  • Reviews documents for completeness and compliance with procedures
  • Support Design Reviews, capturing minutes and action items
  • Maintain Design History, Risk Management and Usability Engineering Files to assure compliance to the company's procedures.
  • Assists in the compilation of regulatory filing documents
  • Work with Quality Manager to support monitoring of quality processes.

Required Education & Experience:

  • 3 to 5 years working knowledge in Document Control or an administrative Quality role in the field of medical devices or related industry
  • Working knowledge of Document Management Systems
  • General knowledge of U.S. and international regulations including FDA, ISO, and cGMP guidance documents.

Preferred Skills and Experience:

  • Bachelor's degree in a related field is an asset
  • Experience with electronic database software, Airtable (https://www.airtable.com)
  • Experience with eQMS software, Greenlight Guru (greenlight.guru)
  • Experience with issue-tracking software, Jira (atlassian.com/software/jira)
Company Description
The VentriFlo® True Pulse PumpTM is a novel, truly pulsatile blood pumping system designed to achieve superior outcomes, reduce costs, and improve safety for pediatric & adult patients who require cardiopulmonary support during surgery or in the intensive care unit (ICU). The initial market entry is surgical pediatric patients.

VentriFlo Inc recognizes the important role that company culture plays in supporting both the individual and the team. VentriFlo, Inc. respects the individual, their ideas and experiences, and each day we benefit from our staff’s diverse perspectives in strengthening competitive and creative advantages. Our supportive environment is based on integrity, mutual respect, trust, and teamwork while valuing individual differences.

VentriFlo Inc recognizes the important role that company culture plays in supporting both the individual and the team. VentriFlo, Inc. respects the individual, their ideas and experiences, and each day we benefit from our staff’s diverse perspectives in strengthening competitive and creative advantages. Our supportive environment is based on integrity, mutual respect, trust, and teamwork while valuing individual differences.

VentriFlo Inc

VentriFlo Inc's Logo

Address

Pelham, NH
USA

Industry

Business

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