Quality Assurance

Actalent•Santa Clara, CA

35d•$27 - $33•Onsite

About The Position

The Quality Training Coordinator II is responsible for managing and maintaining the Quality Management System training program in accordance with FDA, European MDD/MDR, and ISO regulations. This role requires excellent written and verbal communication skills and the ability to organize and process training records in both paper and electronic formats.

Requirements

Document control and management
Quality assurance
Training coordination
Proficiency with QMS
Strong written and verbal communication skills
Bachelor's degree preferred with 3-5 years of relevant experience, or a high school diploma and 5+ years of experience as a Training Coordinator or Document Control Coordinator in a manufacturing environment.
Practical knowledge of cGMP requirements.
Proficiency in MS Word, Excel, and other database systems.
Ability to work in a fast-paced environment while managing multiple priorities.
Self-motivated and proactive.
High attention to detail with the ability to prioritize effectively.
Ability to work independently or as part of a team while adapting to changing requirements.

Nice To Haves

Experience in the medical devices industry is preferred.
Knowledge of Solid Works or other drawing programs is preferred.

Responsibilities

Coordinate with hiring managers to set up training sets for new hires, including technical and Quality Management System procedures.
Collaborate with Manufacturing to maintain Direct Labor training and certification records.
Work with department heads to review and maintain minimum training requirements by function and title.
Manage training tasks for employees on extended leave.
Mentor and train employees on the Virje training system.
Monitor and send out past due training notifications.
Maintain and prepare training metrics for presentation at Management Review.
Ensure suppliers are properly trained to applicable procedures before performing on-site work.
Maintain hard copy training records and send them to off-site storage for archiving as needed.
Support and perform Document Control duties as required.
Review, process, and release documents in the Virje Document Change Order system.
Check revised documents and completed change orders for accuracy and conformance with approved standards.
Support Internal and third-party audits as the subject matter expert on the Training System.
Assist in managing Training Process documentation, including process improvements, Corrective Actions, or Audit finding responses.
Exhibit a working understanding of ISO standards.
Perform other duties as assigned.