Drives the development, coordination, and maintenance of the Reflexion Medical’s Product Lifecycle Management (PLM) Control and Training systems and assures the flow of information in the form of controlled documents. Establish procedures and work instructions needed to meet the demands of document and training control in a medical device company. Responsible for supporting all the documentation, training and compliance needs for a fast paced and dynamic product focused team.
Review and release Change Orders for all document types while maintaining a standard format and approach compliant with applicable standards and regulations.
Support documentation issuance, version control, electronic files maintenance, and document status notifications.
Facilitate the incorporation of quality systems/regulatory requirements in accordance with FDA QSR (21 CFR: Part 820), ISO13485:2016, and all other applicable regulations.
Review and assess software changes made to PLM system.
Perform and support document formatting, printing and update document trackers/logs.
Develop and conduct training regarding controlled document format, content, and usage.
Drive continuous improvement initiatives to change order and training processes.
Implement training profiles, maintain training records and submit document records within RefleXion’s electronic training tracking system.
Develop and maintain a complete and accurate index of all documents.
Oversee issuance and tracking of lab notebooks.
Create and maintain monthly metrics and reports.
Actively participate in department meetings as necessary.
Maintain and update as needed the standards library.
Support internal and external audits and inspections.
Support the development of functionally within the PLM software system in support of NCR/CAPA/SCAR/SCR or other new processes.
Performs all other duties as assigned.
Bachelor’s Degree preferred
Minimum of 3 years of experience in medical device industry required
Knowledge of electronic PLM system software
Ability to work both with others on a project team and independently on tasks
Ability to work effectively in a collaborative and dynamic environment
Leadership and interpersonal skills to develop and manage good working relationships with internal departments (quality, operations, & engineering), strong written and verbal communication skills