TransMedics, Inc. · 14 hours ago
Quality Program Manager
Andover, MA
Full-time
Onsite
Senior Level
$139K/yr - $174K/yr
7+ years expTransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. They are seeking a proactive and strategic Quality Program Manager to lead key elements of their Quality Management System, focusing on the CAPA program and driving cross-functional quality initiatives.
Health CareMedicalMedical DeviceService IndustryWellness
No H1B
Responsibilities
Own and manage the CAPA Program, including administration, investigation quality, timeliness, effectiveness checks, and overall system health
Serve as the organizational CAPA SME, providing guidance on root cause analysis, risk assessment, and effective corrective/preventive actions
Continuously assess and improve QMS processes to ensure regulatory compliance, operational efficiency, and alignment with business goals
Lead the Internal Audit Program, including planning, execution, follow-up, and trending of audit outcomes
Prepare and analyze Quality Metrics and KPIs, providing data-driven insights for Management Review and executive reporting
Partner cross-functionally with Operations, R&D, Regulatory, and other stakeholders to resolve systemic issues and implement sustainable improvements
Support external audits and inspections, serving as a subject matter expert for CAPA and related QMS processes
Author and revise quality documentation (quality plans, procedures, work instructions, templates) to maintain compliance with evolving regulations
Champion a culture of quality and accountability through training, communication, and proactive engagement across all departments
Act as a quality liaison for key initiatives, ensuring integration of QMS principles into new projects and programs
Perform other tasks and duties as required
Qualification
Required
Bachelor's degree in an engineering or technical discipline, or another discipline demonstrating strong analytical, organizational, and communication skills. Equivalent combination of education and directly relevant experience will be considered
7+ years of experience in medical device or IVD industry, with focus on Quality Systems and CAPA management
Strong working knowledge of 21 CFR Part 820, ISO 13485, EU MDR, MDSAP requirements
Demonstrated success leading cross-functional quality initiatives and driving systemic improvements
Proven ability to interpret and apply regulatory requirements to drive improvement of quality system processes
Proficiency in problem-solving and root cause analysis methodologies (RCA, FMEA, 5-Why, etc.)
Excellent analytical, organizational, and communication skills
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Access)
Preferred
Certified Internal Auditor or experience leading internal and external audits
Advanced training or certification in root cause analysis, Six Sigma, or quality engineering methodologies
Demonstrated ability to develop and track meaningful quality metrics and KPIs
Strong interpersonal and influencing skills, with the ability to partner effectively across all levels of the organization
Benefits
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
Company
TransMedics, Inc.
Every Organ Wasted is a Life Not Saved. TransMedics, Inc.
Founded in 1998Andover, Massachusetts, USA
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$721.33MKey Investors
CIBC Innovation BankingAbrams CapitalTudor Investments
2023-05-08Post Ipo Debt· $400M
2022-09-15Post Ipo Debt· $60M
2020-04-24Post Ipo Debt· $2.2M
Leadership Team
Waleed Hassanein
President & CEO
Gerardo Hernandez
Chief Financial Officer
Recent News
2026-01-22
Boston Globe
2026-01-19
FX News Group
2026-01-16
Company data provided by crunchbase