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Technical Documentation Manager ViewRay
SummaryViewRay Incorporated is looking for a technical documentation specialist/manager to join the ViewRay team at our Oakwood Village site. We are a company that values technical excellence, teamwork, and commitment to success. This position will be responsible for managing the technical and procedural documentation management system (DMS).
Responsibilities
Managing the departments, roles, and training courses setup and maintenance within DMS
Ensuring the proper routing of documents for approval and training within DMS
Providing training and guidance to staff regarding the use of the DMS system
Managing the writing, revising, reviewing, and approving of all standard operating procedures (SOPs) and work instructions (WIs)
Managing the PLM process, integrating PDM schematics and drawings with procedural documentation into one system
Maintaining the CCB database, managing the SOP for the day-to-day tracking of CRs/COs, and managing database administration
Ensuring the proper management of SOP and WI documentation and tracking
Providing training and guidance to staff regarding compliance and interpretation of SOPs and WIs
Participating in the development and maintenance of all quality systems and process improvements
Leading and investigating quality issues and implementing corrective actions related to the DMS system; identifying departmental strengths and weaknesses
Supporting the development and implementation of proper document management and change control processes
Assisting with the scheduling, planning, conducting, and reporting of audits
Qualifications
Strong interpersonal and communication skills, both verbal and written
Strong organizational and leadership skills
Goal orientation
Ability to maintain a professional and positive attitude
Bachelor?s degree required, preferably in life sciences; advanced degree preferred
Three or more years of current experience in a regulatory or quality assurance role within the medical device industry required
Three or more years of experience in creating and maintaining SOPs preferred
Demonstrated above average written communication skills
Proven ability to work with and direct teams to accomplish goals
Familiarity with U.S. and EU regulations and guidance required
Experience with PLM tools (i.e., Agile, Windchill)
| Location: | 101 SE Second Place Suite 201D Gainesville, FL 32601 United States |
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ViewRay
Investors: Fidelity Biosciences, Kearny Venture PartnersAll Jobs: at ViewRay
| Web Site: | www.viewray.com |
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| Headquarters: | 101 SE Second Place Suite 201D Gainesville, FL 32601 United States |
| Industry: | Medical Devices and Equipment |
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