Document Control Training Specialist

TransMedics, Inc. • Andover, MA

20h • Onsite

About The Position

This position is a Training Specialist within the Document Control department to aid in the development, delivering and maintaining of training programs related to document control processes, systems, and compliance standards. The ideal candidate will help to develop and implement training strategies within the QMS and provide coaching and support to departments and employees impacted by change initiatives. Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships.

Requirements

• Bachelor's degree or equivalent combination of education and experience.
• 3-5 years’ experience working in a regulated industry

Nice To Haves

• Med Device preferred.
• 3+ years of experience in project management, training, quality systems, or related field.
• Familiarity with regulatory standards (e.g., ISO, FDA, GMP, GDP)
• Excellent presentation, communication, and facilitation skills.
• Strong problem-solving skills with a proactive approach to challenges.
• Ability to work collaboratively in a team-oriented environment.
• Ability to multi-task and manage multiple projects.
• Strong organization and attention to detail abilities.
• Commitment to compliance and ethical standards.
• Proficiency in Microsoft Office and learning management systems (LMS).
• Experience with electronic document management systems (e.g., MasterControl, Omnify/Empower)
• Experience in regulated industries such as medical device, pharmaceuticals)
• Ability to analyze training data and generate reports

Responsibilities

• Help to design and develop training materials for QMS processes.
• Deliver instructor-led and virtual training sessions to employees across departments and sites.
• Provide onboarding training for new hires on QMS and document management procedures.
• Evaluate training effectiveness and update content as needed.
• Ensure training aligns with industry standards.
• Maintain training records and track employee’s completion and competency.
• Support audits by providing documentation and evidence of training compliance.
• Support the operation and improvement of TMDX Training Program including creating / adding curriculum assignments in the training system, creating and distributing training reports, and partnering cross-functionally to provide first line training support.
• Perform other TransMedics tasks and duties, as assigned.

Benefits

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 251-500 employees