New · posted Oct 30
TransMedics · Medical Devices
Senior Software Quality Engineer (Contract)
- Andover, MA
- On-site
- Contract
- Senior & Principal
The role
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 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.
What you need
MINIMUM 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 QUALIFICATIONSnice to have
- 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 Systems space.
What you'll do
This position is responsible for, but not limited to, the following:
- 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 corrective actions in collaboration with IT and vendors.
- 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 throughout the implementation.
- Perform other TransMedics tasks and duties as assigned/required.
MANAGEMENT RESPONSIBILITIES
- This position will not have management responsibilities.
PHYSICAL ATTRIBUTES
- Standard office position
Pay
TransMedics didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
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
Where you'll work
Andover, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Andover, MAEqual opportunity, accessibility and legal noticesTransMedics's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 30, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in Massachusetts10 roles publishing pay
Senior & Principal roles in the US58 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Massachusetts (middle half) | $102,500 | $115,750 | $127,500 |
| All US (middle half) | $106,625 | $121,000 | $132,750 |
Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 30, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 131 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not TransMedics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Data and digital systems8
- Validation and qualification5
- Quality systems and risk4
- GMP and compliance3
- Lab testing and methods2
- Documentation and SOPs2
- Investigations and CAPA2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
TransMedics on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 1
- Locations
By discipline
- Quality5 83%
- Regulatory1 17%
By level
- Associate & Specialist3 50%
- Senior & Principal2 33%
- Manager1 17%
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Senior Software Quality Engineer (Contract) at TransMedics
Open until filled.