Quality Program Manager

TransMedics, Inc.•Andover, MA

3d•Onsite

About The Position

We are seeking a proactive and strategic Quality Program Manager to lead key elements of our Quality Management System (QMS), with primary focus on the Corrective and Preventive Action (CAPA) program. This position plays a key role in driving cross-functional quality initiatives, ensuring regulatory compliance, and fostering a culture of continuous improvement across the organization. The ideal candidate will have a strong background in medical devices or IVD, exceptional analytical and organizational skills, and the ability to lead through influence in a fast-paced environment.

Requirements

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).

Nice To Haves

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.

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