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