Document Control Training Specialist

About the role

This position is a Training Specialist within the Document Control department focused on developing, delivering, and maintaining training programs related to document control processes, systems, and compliance standards. The ideal candidate will help develop and implement training strategies within the Quality Management System (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.

As part of our long-term growth plans, TransMedics is relocating its headquarters to Somerville, MA by 2028. This new state-of-the-art facility is designed to support collaboration, creativity, and innovation in organ transplantation.

Responsibilities

• 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 completion and competency.
• Support audits by providing documentation and evidence of training compliance.
• Support the operation and improvement of the TMDX Training Program, including creating curriculum assignments in the training system, generating training reports, and partnering cross-functionally to provide first-line training support.
• Perform other TransMedics tasks and duties as assigned.

Physical Attributes

This position requires physical capabilities associated with lifting archival boxes up to 25 lbs in a general office environment.

Requirements

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

Preferred Qualifications

• Experience in the medical device industry.
• 3+ years of experience in project management, training, quality systems, or a 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.
• 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 or pharmaceuticals.
• Ability to analyze training data and generate reports.

Pay

The expected base salary range for this role is $76,950.00 – $96,050.00. Actual salary will depend on factors such as candidate experience, qualifications, skills, and work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package.

Benefits

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