Document Control Training Specialist

Job Description:

POSITION SUMMARY

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

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• 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.

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis. - This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

• This position requires physical capabilities associated with archival boxes up to 25lbs.
• General Office Environment

MINIMUM QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

• 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

As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary. Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $76,950.00 – $96,050.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history. Employee Benefit: 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 TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.