Quality Program Manager

TransMedics•Andover, MA

2d•Onsite

About The Position

Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships POSITION SUMMARY This role is onsite in Andover, MA 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. RESPONSIBILITIES This position is responsible for, but not limited to, the following: 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 MANAGEMENT RESPONSIBILITIES This position does not include direct reports but requires strong program management and cross-functional leadership skills to influence and align teams across the organization. PHYSICAL ATTRIBUTES Must be able to lift up to 30lbs Ability to work in Andover office 5 days a week MINIMUM QUALIFICATIONS 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 QUALIFICATIONS 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. Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. 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 TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $139,450.00 – $173,950.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history. Employee Benefit: 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 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.

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