Senior Software Quality Engineer (Contract)

TransMedics; Andover (MA); In loco; USD 110.000 - 150.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical with Health Reimbursement Arm?

Dental

Vision

Healthcare Flexible Spending Account

Dependent Care Flexible Spending?</n>

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

Descrizione del lavoro

TransMedics is seeking a Senior Software Quality Engineer in Massachusetts to lead quality processes and IT-enabled systems. The role focuses on implementing and validating enterprise software within a regulated environment.

You will configure systems, drive IQ/OQ/PQ and UAT, ensure data integrity, and collaborate with IT and vendors to deliver compliant, scalable solutions.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Quality systems

Regulated environment

System configuration

CSV/CSA

Problem solving

Cross-functional work

Strumenti

APIs

Data interfaces

Descrizione del lavoro

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 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 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

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 QUALIFICATIONS

• 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.

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.