QMS Training Admin/QA Engineer

Job Title - Training Administrator / Quality Assurance Engineer 
Job Location – Andover MA
Length – Contract (6 Months+)

 Key areas of responsibilities (KARS) for this role include:
• Effective (local) expert role for Training Administration processes and tools in scope
 • Ensure the assignment of training requirements profiles and documentation for all job’ required training
 • Ensure that managers assign the correct training profiles to all individual employees based on job requirement profiles
 • Provide feedback to users on profile and training compliance and noncompliance
 • Support users on using the Training Management System
 • Establish, monitor and respond to metrics on the efficacy and efficiency of the Training Administration and Control activities and its ability to support the business
 • Administer both profiles and training records in line with regulatory requirements
 • In close cooperation with supervisors and QMS management, administer profiles for all jobs with respect to job effectiveness / qualification, as well as QMS / Regulated Training Management
 • Recommend and drive items to demonstrate training effectiveness improvements
 • 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 Training Administration and Training Effectiveness 
 • 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.
Kushal Shah
APN Software Service INC

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