Manages and 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.
Ensures external and internal audit readiness and provides support during external and internal audits
Manages (local) Q&R processes in scope and ensures Q&R requirements are effective in all processes in scope.
Participates in Quality & Regulatory initiatives as a cross functional contributor
Creates PQMS awareness and establishes PQMS, owns all activities under the PQMS governance in scope and manages deployments.
Accountable to harmonize QMS processes in scope.
Establishes operational objectives and work plans, and delegates assignments to subordinates.
Establishes and assures adherence to schedules, work plans and performance requirements.
Specific skill requirements for this role include:
Bachelor’s degree. plus a minimum of 10 years of related experience in the medical device or another regulated industry
Expert understanding of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR Parts 50, 54, 56, 803, 806, and 812, 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), ANVISA, ISO 14971, ISO 9001 and others
Government/regulatory-body Quality System auditing/inspection experience preferred (i.e., former FDA)
Demonstrates considerable knowledge of, and success with performing on, compliance-related projects
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