Document Control Training Specialist

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

Requirements

• Bachelor's degree or equivalent combination of education and experience.
• 3-5 years' experience working in a regulated industry
• 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
• Every Organ Wasted is a Life Not Saved.
• 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.
• www.TransMedics.com
• Employee Benefit:
• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Depende

Benefits

Additional Information

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

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