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TransMedics, Inc. · 2 weeks ago

Quality Assurance – QMS Technical Lead

Andover, MA

Full-time

Onsite

Senior Level

$132K/yr - $165K/yr

5+ years exp

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. They are seeking a hands-on Quality Technical Lead to perform the technical and operational aspects of their Quality Management System (QMS) transformation initiative, focusing on business systems analysis, process definition, and software testing.

Health CareMedicalMedical DeviceService IndustryWellness

No H1B

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

Qualification

EQMS expertiseQuality Systems experienceSoftware testingSupply Chain knowledgeMedical device experienceRequirements documentationAnalytical skillsStakeholder engagementChange management exposureProblem-solvingCommunication skills