eQMS Implementation Contractor

Job Description

POSITION SUMMARY

We are seeking a highly skilled and experienced eQMS Implementation Consultant 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 eQMS systems. This role requires someone who can take the reins, drive the implementation process, and ensure the system is configured properly to meet our business needs.

This position is in Andover, MA.

Responsibilities

This position is responsible for, but not limited to, the following:

• 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 NCMRs 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.
• Perform other TransMedics tasks and duties as assigned/required.
  
  

Management Responsibilities

• This position will not have management responsibilities.
  
  

Minimum Qualifications

• Proven experience in eQMS implementation, 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.
• 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.
  
  

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.