Job Description:

POSITION SUMMARY

TransMedics is launching a major initiative to transform its Quality Management System (QMS), and we are seeking a hands-on Quality Technical Lead to perform the technical and operational aspects of this effort. This is an individual contributor role with a strong focus on business systems analysis (BSA), process definition, and software testing, not a traditional project manager position. This role requires deep eQMS expertise, strong analytical skills, and a proactive approach to problem-solving. The ideal candidate will bring a supply chain and manufacturing background, understanding of core quality validation processes, deep experience in medical device and regulatory environments, and the ability to bridge IT and business operations. This role will be instrumental in defining and validating processes, gathering requirements, and supporting system testing.

RESPONSIBILITIES

• Lead the technical execution of the QMS transformation project, ensuring it is configured correctly and meets the organization's requirements.
• Define and document process requirements in collaboration with Quality, Manufacturing, and Supply Chain teams.
• Perform software testing and QA validation (non-regulatory) to ensure system functionality and alignment with business needs.
• Act as a technical SME on QMS systems, supporting configuration, testing, and implementation.
• Collaborate with Quality to ensure system capabilities meet operational and compliance requirements.
• Support SEO, manufacturing, and engineering teams in transitioning to new digital quality workflows.
• Drive hands-on execution of testing, validation, and process mapping activities.
• Provide input into future PMO structure and governance as the quality function matures.

MANAGEMENT RESPONSIBILITIES

• No direct reports (This position will not have management responsibilities).

PHYSICAL ATTRIBUTES

• None (Standard office environment).                                                                            

MINIMUM QUALIFICATIONS                                                    

• Bachelor’s degree in Information Systems or related field.
• 5–8+ years of experience with eQMS systems, including hands-on configuration and support.  Familiarity with MasterControl a plus.
• Strong experience in Quality Systems, Supply Chain, and Manufacturing within medical device and regulated environments.
• Proven experience in eQMS implementation, with a strong understanding of quality processes and IT interfaces.
• Proven ability to implement technical programs and define business processes.
• Experience with software testing, QA validation, and requirements documentation.
• Understanding of QMS platforms and their integration with IT systems.
• Ability to work independently and drive initiatives as an individual contributor.
• Strong communication and stakeholder engagement skills.
• Program management experience with a technical edge; ability to balance IT and business needs.

PREFERRED QUALIFICATIONS

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.