Job Title - Training Administrator / Quality Assurance Engineer
Job Location – Andover MA
Length – Contract (6 Months+)
Responsibilities:
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.
Best,
Kushal Shah
APN Software Service INC