Document Control Specialist/QA Engineer

Key areas of responsibilities (KARS) for this role include: 
 • Effective (local) expert role for Document Control processes and tools in scope 
 • Provide local Document Control support to authors and local process owners in defining and producing lean Quality System documents and records 
 • Ensure proper quality of the content of documentation and records 
 • Improve review process 
 • Ensure availability/publishing of controlled documents 
 • Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business 
 • Maintains a compliant and effective QMS for the activities in scope (including, but not limited to addressing compliance deficiencies) as well as for effective and lean QMS structure and documents for Q&R processes in scope. 
 • Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies in scope are consistent with those regulations. 
 • Manages (local) Q&R processes in scope and ensures Q&R requirements are effective in all processes in scope. 
 • Ensures external and internal audit readiness and provides support during external and internal audits 
 • Participates in Quality & Regulatory initiatives as a cross functional contributor 
 
 Specific skill requirements for this role include: 
 • Quality Management Systems Process Expert 
 • Bachelor’s degree plus a minimum of 6 years of related experience in the medical device with focus on change control and or Document Control field 
 • Familiarity with Document Management System tools 
 • Experience running effective process improvement projects 
 • Expert understanding of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), ISO 14971, ISO 9001, and others 
 • Government/regulatory-body Quality System auditing/inspection experience preferred 
 • Demonstrates considerable knowledge of, and success with performing on, compliance-related projects, e.g. including (but not limited to: developing and assessing compliance programs, constructing, monitoring and auditing programs, managing internal risk assessments and/or investigations, implementing compliance solutions 
 • Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations 
 • A comprehensive understanding of the diverse worldwide medical device quality regulations 
 • An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization 
 • Experience with deployment of Quality Management System processes as identified 
 • Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management; 
 • Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor 
 • Attention to detail 
 • Solid organizational and interpersonal skills 
 • Ability to analyze information and come to conclusions based on presented data 
 • Ability to communicate effectively both orally and in writing 
 • Manage time working on multiple projects simultaneously 
 • Open to other’s ideas and working collaboratively across functions and/or businesses 

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