{"schemaVersion":"jobsearcher.job.v1","id":"ef4b303368f213436a966b4e","url":"https://jobsearcher.com/jobs/ef4b303368f213436a966b4e","canonicalUrl":"https://jobsearcher.com/jobs/ef4b303368f213436a966b4e","title":"Quality Program Manager","description":"Job Description:\nPlease note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships\nPOSITION SUMMARY\nThis role is onsite in Andover, MA\nWe 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.\nRESPONSIBILITIES\nThis position is responsible for, but not limited to, the following:\nOwn and manage the CAPA Program, including administration, investigation quality, timeliness, effectiveness checks, and overall system health.\nServe as the organizational CAPA SME, providing guidance on root cause analysis, risk assessment, and effective corrective/preventive actions.\nContinuously assess and improve QMS processes to ensure regulatory compliance, operational efficiency, and alignment with business goals.\nLead the Internal Audit Program, including planning, execution, follow-up, and trending of audit outcomes.\nPrepare and analyze Quality Metrics and KPIs, providing data-driven insights for Management Review and executive reporting.\nPartner cross-functionally with Operations, R&D, Regulatory, and other stakeholders to resolve systemic issues and implement sustainable improvements.\nSupport external audits and inspections, serving as a subject matter expert for CAPA and related QMS processes.\nAuthor and revise quality documentation (quality plans, procedures, work instructions, templates) to maintain compliance with evolving regulations.\nChampion a culture of quality and accountability through training, communication, and proactive engagement across all departments.\nAct as a quality liaison for key initiatives, ensuring integration of QMS principles into new projects and programs.\nPerform other tasks and duties as required\nMANAGEMENT RESPONSIBILITIES\nThis position does not include direct reports but requires strong program management and cross-functional leadership skills to influence and align teams across the organization.\nPHYSICAL ATTRIBUTES\nMust be able to lift up to 30lbs\nAbility to work in Andover office 5 days a week\nMINIMUM QUALIFICATIONS\nBachelor’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.\n7+ years of experience in medical device or IVD industry, with focus on Quality Systems and CAPA management\nStrong working knowledge of 21 CFR Part 820, ISO 13485, EU MDR, MDSAP requirements\nDemonstrated success leading cross-functional quality initiatives and driving systemic improvements.\nProven ability to interpret and apply regulatory requirements to drive improvement of quality system processes.\nProficiency in problem-solving and root cause analysis methodologies (RCA, FMEA, 5-Why, etc.).\nExcellent analytical, organizational, and communication skills.\nProficiency in Microsoft Office tools (Word, Excel, PowerPoint, Access).\nPREFERRED QUALIFICATIONS\nCertified Internal Auditor or experience leading internal and external audits.\nAdvanced training or certification in root cause analysis, Six Sigma, or quality engineering methodologies.\nDemonstrated ability to develop and track meaningful quality metrics and KPIs.\nStrong interpersonal and influencing skills, with the ability to partner effectively across all levels of the organization.\n\nEvery Organ Wasted is a Life Not Saved.\nTransMedics, 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.\nDriven 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.\nMaximize your potential at TransMedics, Inc.\nwww.TransMedics.com\nTransMedics 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.\nEmployee Benefit:\n\nMedical with Health Reimbursement Account through Blue Cross/Blue Shield of MA\nDental\nVision\nHealthcare Flexible Spending Account\nDependent Care Flexible Spending Account\nShort Term Disability\nLong Term Disability\n401K Plan\nPet insurance\nEmployee Stock Purchase Plan\nTransMedics 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.","company":"Transmedics","rawCompany":"transmedics","city":"Andover","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-04-12T17:43:31.998Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-9199.02","title":"Compliance Managers","slug":"compliance-managers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Program Manager","description":"Job Description:\nPlease note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships\nPOSITION SUMMARY\nThis role is onsite in Andover, MA\nWe 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.\nRESPONSIBILITIES\nThis position is responsible for, but not limited to, the following:\nOwn and manage the CAPA Program, including administration, investigation quality, timeliness, effectiveness checks, and overall system health.\nServe as the organizational CAPA SME, providing guidance on root cause analysis, risk assessment, and effective corrective/preventive actions.\nContinuously assess and improve QMS processes to ensure regulatory compliance, operational efficiency, and alignment with business goals.\nLead the Internal Audit Program, including planning, execution, follow-up, and trending of audit outcomes.\nPrepare and analyze Quality Metrics and KPIs, providing data-driven insights for Management Review and executive reporting.\nPartner cross-functionally with Operations, R&D, Regulatory, and other stakeholders to resolve systemic issues and implement sustainable improvements.\nSupport external audits and inspections, serving as a subject matter expert for CAPA and related QMS processes.\nAuthor and revise quality documentation (quality plans, procedures, work instructions, templates) to maintain compliance with evolving regulations.\nChampion a culture of quality and accountability through training, communication, and proactive engagement across all departments.\nAct as a quality liaison for key initiatives, ensuring integration of QMS principles into new projects and programs.\nPerform other tasks and duties as required\nMANAGEMENT RESPONSIBILITIES\nThis position does not include direct reports but requires strong program management and cross-functional leadership skills to influence and align teams across the organization.\nPHYSICAL ATTRIBUTES\nMust be able to lift up to 30lbs\nAbility to work in Andover office 5 days a week\nMINIMUM QUALIFICATIONS\nBachelor’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.\n7+ years of experience in medical device or IVD industry, with focus on Quality Systems and CAPA management\nStrong working knowledge of 21 CFR Part 820, ISO 13485, EU MDR, MDSAP requirements\nDemonstrated success leading cross-functional quality initiatives and driving systemic improvements.\nProven ability to interpret and apply regulatory requirements to drive improvement of quality system processes.\nProficiency in problem-solving and root cause analysis methodologies (RCA, FMEA, 5-Why, etc.).\nExcellent analytical, organizational, and communication skills.\nProficiency in Microsoft Office tools (Word, Excel, PowerPoint, Access).\nPREFERRED QUALIFICATIONS\nCertified Internal Auditor or experience leading internal and external audits.\nAdvanced training or certification in root cause analysis, Six Sigma, or quality engineering methodologies.\nDemonstrated ability to develop and track meaningful quality metrics and KPIs.\nStrong interpersonal and influencing skills, with the ability to partner effectively across all levels of the organization.\n\nEvery Organ Wasted is a Life Not Saved.\nTransMedics, 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.\nDriven 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.\nMaximize your potential at TransMedics, Inc.\nwww.TransMedics.com\nTransMedics 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.\nEmployee Benefit:\n\nMedical with Health Reimbursement Account through Blue Cross/Blue Shield of MA\nDental\nVision\nHealthcare Flexible Spending Account\nDependent Care Flexible Spending Account\nShort Term Disability\nLong Term Disability\n401K Plan\nPet insurance\nEmployee Stock Purchase Plan\nTransMedics 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.","datePosted":"2026-04-12T17:43:31.998Z","dateModified":"2026-04-12T17:43:31.998Z","hiringOrganization":{"@type":"Organization","name":"Transmedics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Andover","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ef4b303368f213436a966b4e"},"url":"https://jobsearcher.com/jobs/ef4b303368f213436a966b4e"}}