Training Specialist, Quality Systems
Responsibilities The position is responsible for assessing, developing and maintaining the Corporate Quality Management System training and document control requirements in compliance with applicable U.S. and international standards and regulations for medical devices. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Ensure that the corporate quality system training practices, processes and systems comply with all applicable national and international regulations, including FDA Quality System Regulations (QSR, cGMPs) and ISO 13485:
2016, Medical Device Directive (MDD) and Regulation (MDR). Administer the corporate training Learning Management System (LMS) to establish and document skill and procedural-based training for corporate employees. This includes assignment of employee training courses, tracking of course completion and confirmation that required training plans have been met to release new/revised process documentation. Aide in the development, application and maintenance of the corporate quality system training matrices requirements for roles within the corporate functional areas. Support site training personnel with implementation of training programs. Identify best practices and process improvements for training identification, implementation, completion, and methods for evaluating training effectiveness. Work with Information Systems to identify and deploy system efficiencies in conjunction with process improvements. Assist in the administration of the corporate document change management system, including change processing, organization of master documents, and archival of historical documents. Review and manage change records to ensure the information is accurate and complete, including implementation strategies to fulfill training requirements. Promote and provide guidance in Good Documentation Practices. Support Record Management, Retention and Repository activities and processes.
Qualifications Education:
Bachelors degree in Science or Education 3-5 years experience in quality assurance or regulatory compliance in FDA regulated field Minimum of 4 years experience in quality assurance training using software training solutions Medical device background preferred Experienced with evaluation, implementation and oversight of internal and external training programs Knowledge of FDA regulations, ISO Standards and MDD/EUMDR laws/regulations Excellent communication skills; experience facilitating training program required Proficient in the use of Microsoft Office Ability and willingness to travel
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
2016, Medical Device Directive (MDD) and Regulation (MDR). Administer the corporate training Learning Management System (LMS) to establish and document skill and procedural-based training for corporate employees. This includes assignment of employee training courses, tracking of course completion and confirmation that required training plans have been met to release new/revised process documentation. Aide in the development, application and maintenance of the corporate quality system training matrices requirements for roles within the corporate functional areas. Support site training personnel with implementation of training programs. Identify best practices and process improvements for training identification, implementation, completion, and methods for evaluating training effectiveness. Work with Information Systems to identify and deploy system efficiencies in conjunction with process improvements. Assist in the administration of the corporate document change management system, including change processing, organization of master documents, and archival of historical documents. Review and manage change records to ensure the information is accurate and complete, including implementation strategies to fulfill training requirements. Promote and provide guidance in Good Documentation Practices. Support Record Management, Retention and Repository activities and processes.
Qualifications Education:
Bachelors degree in Science or Education 3-5 years experience in quality assurance or regulatory compliance in FDA regulated field Minimum of 4 years experience in quality assurance training using software training solutions Medical device background preferred Experienced with evaluation, implementation and oversight of internal and external training programs Knowledge of FDA regulations, ISO Standards and MDD/EUMDR laws/regulations Excellent communication skills; experience facilitating training program required Proficient in the use of Microsoft Office Ability and willingness to travel
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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