MES Quality Engineer II

3 days ago


Elkton, Maryland, United States Terumo Medical Corporation Full time
Job Summary

The MES Quality Engineer II position plays a critical role in ensuring the successful implementation of Manufacturing Execution System (MES) projects. This role will work closely with cross-functional teams to drive continuous improvement and ensure compliance to Terumo's quality policy.

Key Responsibilities
  1. Collaborate with IT, Operations, Validation, and Engineering teams to implement MES projects compliantly and in a timely manner.
  2. Support production to drive continuous improvement and ensure compliance to quality policy.
  3. Develop and/or revise MES requirements documentation, procedures, control plans, PFMEAs, and training materials.
  4. Maintain the compliance of the MES, the integrity of its validated state, and the eDHR.
  5. Proactively identify requirements gaps, investigate, and implement best-in-class Quality Engineering practices and solutions.
  6. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues related to MES.
  7. Develop MES validation test cases and support Software Verification & Validation activities.
  8. Support the Elkton, MD site as a subject matter expert (SME) related to MES and the integration with Product Life Cycle Management.
  9. Develop training strategy plans and support MES team to deliver training on MES processes.
  10. May need to work across shifts during some phases of MES deployments.
Requirements

The ideal candidate will possess a Bachelor's degree in engineering, engineering technology, computer science, or a technical field, with at least three years of experience in a medical device or highly regulated industry. Experience working in a manufacturing environment and implementing and maintaining a Manufacturing Execution System/eDHR is preferred.

The candidate should have excellent communication skills, both verbal and written, and be able to work as a team member on cross-functional teams. Strong problem-solving and critical thinking skills, along with detail and results-oriented approach, are essential for this role.



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