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Document Control Specialist (Cottonwood Heights, UT) - Salt Lake City, UT

Quick Facts
Company Name:Dynatronics Corporation
Location:Salt Lake City, UT
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Description

Seeking a Document Control Specialist to develop, administer, maintain, and monitor Dynatronics' document control activities in accordance with FDA/QSR, ISO 13485 and other international regulations. SUPERVISORY RESPONSIBILITY Not applicable ESSENTIAL FUNCTIONS & * Primarily responsible for implementation and maintenance of the Company document control system * Establish/maintain procedures for inspection readiness, good documentation practices, and change control * Prepare and record changes to official documents and confirm changes with legal and compliance management staff * Coordinate with all document authors/users to ensure all documents are filed in appropriate location and document control is maintained and effective * "Proof" review during document initiation or changes to ensure basic are met for specifically required elements (i.e., header, footer, style, formatting, required approvals) and ensure the organization's needs for documentation infrastructure are met, with compliance to all applicable statutory and regulatory * Conduct needs assessments to identify document management of departments or end users * Prepare support documentation and training materials for end users of document management systems * Monitor regulatory activity to maintain compliance with records and document management laws * Ensure documents and records meet quality standards * Assist in determining document management policies to facilitate efficient, legal, and secure access to electronic content * Develop or configure document management system features, such as user interfaces, access profiles, and document workflow procedures * Ensure documents follow the standard format and reviews quality records to minimize typographical errors and other types of documentation errors * Maintains onsite and offsite documentation storage as applicable * Interacts with all functions of the organization including R&D, Quality, Regulatory, Clinical, Marketing, Sales, Manufacturing and Purchasing to support Documentation Control activities * Evaluate and develop improved techniques and use of tools for the control of documents and quality records, including but not limited to the assessment, acquisition, or deployment of new electronic document management systems. * When applicable, implement electronic document processing, retrieval, and distribution systems in collaboration with other information technology specialists * Keep abreast of developments in document management technologies and techniques by reviewing current literature, talking with colleagues, participating in educational programs, attending meetings or workshops, or participating in professional organizations or conferences * Participate in on-site inspections by internal personnel or external agencies * Perform additional duties as needed. COMPETENCIES * Knowledge of regulatory for medical devices in global markets, including US, EU and Canada * Ability to make effective decisions and execute an appropriate course of action that complies with quality and regulatory while supporting business objectives * Ability to review, analyze, summarize, and interpret data, conduct root-cause investigations, and prepare reports on findings * Influential, high level of verbal and written (including technical writing) communication skills * Extreme attention to detail * Time management, project management, and organizational skills; able to perform a wide variety of tasks and multi-task efficiently * Ability to remain calm under pressure and work to deadlines * Ability to build strong relationships and work effectively cross-functionally * Strong attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects simultaneously * Ability to handle sensitive and proprietary information with discretion and confidentiality * Continuous improvement and proactive mindset * "Quality #1" commitment * Ability to work independently with minimal supervision and to work on a team * Strong organizational and time-management skills * Proficient in Microsoft Office (Outlook, Word, Excel) Experience & Education: * Minimum 1 year of experience in the medical device industry with demonstrated quality system knowledge including 21 CFR Part 820 (QSR) & ISO 13485 * Direct experience in document control processes within a regulated environment * Basic understanding of Engineering specifications and drawings and supporting the release of engineering/manufacturing documentation as required * Expert knowledge/understanding of regulatory governing document control preferred * College degree preferred To Apply: * To be considered for this position, submit your cover letter and resume to ...@dynatronics.com.SDL2017.

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