Quality Assurance

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.

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.

• 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.
• Experience in the medical devices industry is preferred.
• Practical knowledge of cGMP requirements.
• Proficiency in MS Word, Excel, and other database systems.
• Knowledge of Solid Works or other drawing programs is preferred.
• 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.

The work environment is a quality lab setting, offering a dynamic and collaborative space for professionals dedicated to maintaining high standards in quality assurance and training.

Job Type & Location

This is a Contract position based out of Santa Clara, CA.

Pay and Benefits

The pay range for this position is $27.00 - $33.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Santa Clara,CA.

Application Deadline

This position is anticipated to close on Dec 5, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $27 - $33