Training Specialist I

Cordis • Irvine, CA

13d • Onsite

About The Position

Selution, in partnership with Cordis, specializes in the development of groundbreaking technology and commercialization of advanced drug-device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Requirements

• Bachelor’s degree or equivalent education and experience; or an advanced degree with no previous professional experience.
• Strong sense of urgency, attention to detail, and commitment to quality.
• Ability to identify opportunities for improving the training program.
• Ability to effectively communicate and engage with all levels of personnel
• Proficiency in MS Office applications (Word, Excel, Outlook).
• Knowledge of ISO 13485, FDA 21 CFR Part 820, or similar quality system standards.
• Fluent in English

Nice To Haves

• 3+ years of working experience as a Training Coordinator or related experience
• 1+ year of experience working with LMS such as ComplianceWire
• 3+ years of training experience in the regulated environment.
• 3+ years of relevant experience in the medical device industry.

Responsibilities

• Providing administrative and operational support for the training function in Document Control.
• Interacting with multifunctional personnel in the organization, ensuring proper management of training assignments, curriculum assignments and updates, training records and related quality records.
• Maintaining the training program, ensuring compliance with training requirements, training timeliness, and audit readiness.
• Identifying training needs, assigning and maintaining training curriculum in the ComplianceWire Learning Management System (LMS).
• Supporting trainers to develop training materials/quizzes for learning assessment.
• Working with functional managers to identify training needs for new hires or internally transferred employees.
• Working with functional managers to develop, update, and maintain training curriculum needed for specific job functions.
• Working with change order owners on training curriculum updates per procedural requirements.
• Working with management to develop training programs and coordinate training schedules supporting the company's training needs.
• Supporting trainers to develop training materials and/or training quizzes, as needed, to ensure training effectiveness.
• Managing training schedules and tracking new hire training progress (completion of training assignments and training plan in a timely manner).
• Ensuring timely completion of procedural training in accordance with the change order implementation plan.
• Performing general filing and training record keeping for instructor-led training records.
• Communicating training information, training schedules, and due dates.
• Assisting with training data review and KPI reporting as needed.
• Assisting with training procedure updates, process improvements, and other quality-related duties as assigned.
• Providing support for audit activities as needed.
• Assisting in continuous improvement initiatives, including CAPA and procedure updates as needed.
• Performing other quality and training-related duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level