Training Specialist I

Overview

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.

Responsibilities

The Training Specialist I is responsible for providing administrative and operational support for the training function in Document Control. This position interacts with multifunctional personnel in the organization, ensuring proper management of training assignments, curriculum assignments and updates, training records and related quality records.

The role is essential to maintaining the training program, ensuring compliance with training requirements, training timeliness, and audit readiness.

Key Responsibilities

Key duties of Training Specialist I include identifying training needs, assigning and maintaining training curriculum in the Compliance. Wire Learning Management System (LMS), supporting trainers to develop training materials/quizzes for learning assessment. Training Needs: Working with functional managers to identify training needs for new hires or internally transferred employees.

Training Curriculum: 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. Program Development: 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. Administrative Tasks: 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. Communication: 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. Assist in continuous improvement initiatives, including CAPA and procedure updates as needed. Perform other quality and training-related duties as assigned.

Qualifications

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 Preferred Qualifications: 3+ years of working experience as a Training Coordinator or related experience 1+ year of experience working with LMS such as Compliance. Wire 3+ years of training experience in the regulated environment.

3+ years of relevant experience in the medical device industry. Key Competencies Precise, rigorous, and detail-oriented approach to documentation. Strong communication and interpersonal skills, with the ability to collaborate across departments. Organized, self-motivated, and capable of handling multiple priorities. Supportive attitude and commitment to quality and compliance.

Demonstrated integrity and accountability in document handling and record maintenance. Working Conditions Primarily office-based work environment. Requires occasional handling of documentation archives. Standard Monday–Friday schedule, with occasional overtime to meet project deadlines. Pay / Compensation The expected pre-tax pay rate for this position is $61,050 – 77,000 per year.

Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge, and location. The Training Specialist I is responsible for providing administrative and operational support for the training function in Document Control. This position interacts with multifunctional personnel in the organization, ensuring proper management of training assignments, curriculum assignments and updates, training records and related quality records.

The role is essential to maintaining the training program, ensuring compliance with training requirements, training timeliness, and audit readiness.

Key Responsibilities

Key duties of Training Specialist I include identifying training needs, assigning and maintaining training curriculum in the Compliance. Wire Learning Management System (LMS), supporting trainers to develop training materials/quizzes for learning assessment. Training Needs: Working with functional managers to identify training needs for new hires or internally transferred employees.

Training Curriculum: 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. Program Development: 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. Administrative Tasks: 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. Communication: 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. Assist in continuous improvement initiatives, including CAPA and procedure updates as needed. Perform other quality and training-related duties as assigned. Required Qualifications: 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 Preferred Qualifications: 3+ years of working experience as a Training Coordinator or related experience 1+ year of experience working with LMS such as Compliance. Wire 3+ years of training experience in the regulated environment. 3+ years of relevant experience in the medical device industry. Key Competencies Precise, rigorous, and detail-oriented approach to documentation.

Strong communication and interpersonal skills, with the ability to collaborate across departments. Organized, self-motivated, and capable of handling multiple priorities. Supportive attitude and commitment to quality and compliance. Demonstrated integrity and accountability in document handling and record maintenance.

Working Conditions Primarily office-based work environment. Requires occasional handling of documentation archives. Standard Monday–Friday schedule, with occasional overtime to meet project deadlines. Pay / Compensation The expected pre-tax pay rate for this position is $61,050 – 77,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge, and location.