NEED SOMEONE TO SUPPORT ONGOING PROJECTS FROM THE ONGOING QUALITY VALIDATION SIZE . WILL NOT HAVE TO WORK ON THE EQMS IMPLEMENTATION . SHE IS MOVING SOMEONE ON HER TEAM TO EQMS.

Needs someone that can work cross functionally with the IT team

Med device is preferred, if not then pharma or biotech. Need to have one of these.

Key Responsibilities:

• Lead the implementation of the eQMS system, ensuring it is configured correctly and meets the organization's requirements.
• Collaborate with quality teams and IT to manage dependencies and ensure seamless integration.
• Digitize and streamline existing paper-based processes, handling approximately 300 MCRs per month.
• Attend meetings, engage with consultants, and provide granular-level guidance throughout the implementation.
• Build a global architecture to support the organization's expanding manufacturing footprint.
• Communicate effectively with vendors and stakeholders, ensuring flexibility and adaptability.
• Drive the project proactively, bringing together cross-functional teams and anticipating potential challenges.

Required Qualifications:

• Proven experience with a strong understanding of quality processes and IT interfaces.
• Ability to work cross-functionally with quality teams, IT, and other stakeholders.
• Strong organizational skills, with the ability to manage complex projects and timelines.
• Experience in building global architectures and supporting global manufacturing operations.
• Excellent communication and vendor management skills.
• Ability to navigate and resolve issues as they arise, working proactively to drive the project forward.
• Strong soft skills, including the ability to assimilate with various groups, work collaboratively, and break out of their shell.

Preferred Qualifications:

• Experience in automating manufacturing processes and moving to a global manufacturing footprint.
• Business expertise to drive the project and bring everyone together, looking around corners to anticipate challenges.

Soft Skills:

• Ability to work cross-functionally and navigate difficult processes.
• Problem-solving skills and the ability to resolve issues as they arise.
• Strong interpersonal skills, with the ability to assimilate with various groups and drive the project proactively.

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

• 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

• N/A                                                                                                                        

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.