Senior Software Quality Engineer
TransMedics, Inc.
Summary
We are seeking a highly skilled and experienced Senior Software Quality Engineer to join our team. The ideal candidate will have a strong background in computer system validation, quality processes and IT, with a proven track record of successfully implementing software and IT systems. This role sits within Quality but works in close partnership with IT to implement and support systems that enable compliant, efficient, and scalable business processes.
Job description
Position Summary
We are seeking a highly skilled and experienced Senior Software Quality Engineer to join our team. The ideal candidate will have a strong background in computer system validation, quality processes and IT, with a proven track record of successfully implementing software and IT systems. This role sits within Quality but works in close partnership with IT to implement and support systems that enable compliant, efficient, and scalable business processes.
The ideal candidate will bring a strong balance of technical aptitude and quality systems expertise, with the ability to independently execute system configurations, lead validation activities, and translate business needs into practical, compliant system solutions.
Responsibilities
- Lead configuration, setup, and deployment of enterprise software systems supporting Quality and cross-functional processes.
- Perform independent review and approval of software validation documentation (e.g. plans, protocols, reports) as the Quality representative, ensuring compliance with regulatory and internal requirements.
- Partner closely with IT to support system integrations, data structures, access controls, and technical troubleshooting.
- Translate business and quality process requirements into system configurations, workflows, and scalable solutions.
- Lead and execute system validation activities (e.g., IQ/OQ/PQ, UAT), ensuring compliance with applicable regulatory requirements.
- Troubleshoot system issues, perform root cause analysis, and implement data migration, data integrity checks, and system updates/enhancements.
- Drive system testing efforts, including test strategy, defect tracking, and resolution.
- Collaborate with cross-functional teams to manage dependencies and ensure seamless integration.
- Attend meetings, engage with consultants, and provide granular-level guidance.
Qualifications
- 5+ years of experience implementing or supporting enterprise software systems (e.g. QMS, ERP, PLM, MES or similar platforms).
- Strong working knowledge of quality system processes (e.g., CAPA, complaints, audits, change control) in a regulated environment.
- Hands-on experience with system configuration, testing, validation, and troubleshooting.
- Experience with software validation principles (CSV/CSA) and data integrity requirements.
- Proven ability to work cross-functionally with both technical (IT) and non-technical stakeholders.
- Strong problem-solving skills with the ability to diagnose issues and independently drive resolution.
- Ability to manage multiple priorities and drive work forward in a fast-paced environment.
- Strong communication and collaboration skills.
Preferred Requirements
- Experience in medical device, pharmaceutical, or other regulated industries.
- Experience supporting system integrations and working with APIs or data interfaces (high-level understanding).
- Experience with digital transformation initiatives and large-scale system implementations.
- Experience supporting global or multi-site system deployments.
- Ability to mentor others and provide technical guidance within the Quality team.
Requirements
- 5+ years of experience implementing or supporting enterprise software systems (e.g. QMS, ERP, PLM, MES or similar platforms)
- Strong working knowledge of quality system processes (e.g., CAPA, complaints, audits, change control) in a regulated environment
- Hands-on experience with system configuration, testing, validation, and troubleshooting
- Experience with software validation principles (CSV/CSA) and data integrity requirements
- Proven ability to work cross-functionally with both technical (IT) and non-technical stakeholders
- Strong problem-solving skills with the ability to diagnose issues and independently drive resolution
- Ability to manage multiple priorities and drive work forward in a fast-paced environment
- Strong communication and collaboration skills
Benefits
- Medical, Dental & Vision
- Healthcare FSA
- Dependent Care FSA
- Short & Long Term Disability
- 401(k) Plan
- Pet Insurance
- Employee Stock Purchase Plan
- Paid Time Off
Company overview
TransMedics, Inc. is a commercial-stage medical technology company revolutionizing organ transplant therapy for patients worldwide. Founded in 1998 and headquartered in Andover, Massachusetts, the company has developed the innovative Organ Care System (OCS™) technology platform that transforms organ preservation from static cold storage to dynamic perfusion systems. The OCS is the only FDA-approved technology for lung, heart, and liver transplant indications in the United States, enabling the optimization and assessment of donor organs outside the human body. This groundbreaking technology replicates near-physiologic conditions where the lung breathes, the heart beats, and the liver produces bile while being transported. TransMedics operates the National OCS Program (NOP), featuring a nationwide team of clinical experts, 24/7 logistics support, and a dedicated air and ground transport network. The company's mission focuses on increasing access to viable donor organs for transplant patients, addressing the critical shortage of transplantable organs. With over 25 years of commitment to innovation, TransMedics has established itself as a leader in advancing the field of organ transplantation through its comprehensive technology platform and clinical expertise.