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 Support 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
TransMedics is committed to equitable and transparent compensation. The expected salary for this role is $95,000 - $110,000 which represents the company's current good-faith estimate of compensation for this position. Actual hour rate will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. Hourly roles may also be eligible for overtime, shift differentials, incentive programs, and our 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
