This position is responsible for the management of the Quality Compliance Training program in accordance with applicable regulations, standards and established internal procedures/policies required to ensure the demands of a compliant training system in a regulated medical device company are met.
Identify and coordinate learning opportunities for existing employees to ensure job responsibilities and expectations are met to improve performance and address gaps appropriately
Evaluate and schedule regular review of policy and process changes impacting training documentation and quality monitoring practices to ensure alignment with operational practices
Management and oversight of the Document Control function within the Quality Assurance group. This individual manages the life cycle of controlled documents: in collaboration with the document owners, performs administrative tasks to support and coordinate the creation, revision, approval, and retirement of controlled documents (such as SOPs), forms, templates, protocols/reports etc. Is responsible for maintaining both electronic and paper document control systems; manages the work flows in QDMS systems (an e- documentation management system) for controlled documents.
Quality Training Management
Develops, implements, and maintains an effective training program utilizing an electronic management (MC, LMS) and paper-based systems.
Develop learning solutions, training content, activities and development programs
Identifies and assesses future and current training needs through job descriptions, career paths, and consultation with managers.
Collaborates and communicates with cross-functional team members to ensure timely completion of training.
Collaborate with subject matter experts (SMEs) and internal stakeholders to understand learning scope and vision. Work closely with them to prepare appropriate content for programs including training materials, leader guides, related activities and tools
Deploys a variety of training methods.
Develop and lead learning assessment tools and metrics to measure post training effects on employees and measure progress against desired state
Generates, analyzes, and presents departmental metrics on a monthly basis.
Creates, revises, and reviews SOPs related to areas of responsibility.
Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis.
Manage and improve the global document control process and deliverables in all our departments according to multiple regulations (ISO 13485; 21 CFR 820; MDD, etc)
Support the improvement of process work flows and process deliverables for document control functions in different company locations.
Organize and manage a centralized document control center (DCC) for the company (globally).
Organize and manage documents templates library (QSPs, SOPs, Presentations, etc)
Support the analysis, selection, and implementation of document management software packages including integration of systems (Master Control, Agile, SAP).
Serve as Master Control system owner for Document Control and Training processes from Quality perspective opposite to IT ownership..
Responsible for implementation, management, and enhancements of an electronic Document Management System (eDMS).
Ensure document management procedures are being consistently followed throughout the organization.
Ensures completeness and accuracy of information contained in all documents, document files
Establishes and maintains the lifecycle of controlled documents, including but not limited
to: records management system including version control, document distribution, archival, retrieval, retention and destruction.
Ensue the latest revisions of required documents are available by managing the procurement and subscription service for external technical and regulatory documents
Manage, maintain and co-ordinate storage and retrieval of records that are archived off-site
Engineer/Science qualification (Minimum BSc) with minimum of 3 years working as a document control/ QA engineer in a multi-national medical devices manufacturing & distribution environment.
Knowledge of quality systems and regulatory requirements (21 CRF Part 11 and 820, ISO 13485)
Strong knowledge with quality system regulations.
Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
Ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
Previous experience developing and implementing a robust document control and training program.
Previous experience with Master Control and Agile software preferred.
Working knowledge of GDP
Willingness to travel to various company sites for face to face trainings