MES Quality Engineer II

1 week ago


Elkton, Minnesota, United States Terumo Full time
Job Summary

The MES Quality Engineer II position plays a critical role in ensuring the successful implementation of Manufacturing Execution Systems (MES) projects at Terumo Medical Corporation. This role will work closely with cross-functional teams to ensure compliance and timely delivery of projects related to MES.

Key Responsibilities
  • Act as an integrated MES team member to support new MES deployments, sustaining, and optimization projects
  • Develop and/or revise MES requirements documentation, procedures, control plans, PFMEAs, and training materials
  • Maintain the compliance of the MES, the integrity of its validated state, and the eDHR
  • Proactively identifies requirements gaps, investigates, and implements best-in-class Quality Engineering practices and solutions
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues related to MES
  • Develop MES validation test cases and support Software Verification & Validation activities
  • Support the Elkton, MD site as a subject matter expert (SME) related to MES and the integration with Product Life Cycle Management
  • Develop training strategy plans and support MES team to deliver training on MES processes
Requirements
  • Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC
  • Excellent communication skills; verbal and written
  • Ability to work as a team member on cross-functional teams and with employees across all levels within the facility
  • Excellent computer skills and working knowledge of Microsoft Office Suite
  • Problem-solving and critical thinking
  • Detail and results-oriented
  • Self-motivated and driven
  • Ability to multitask, prioritize, and provide deliverables within the required timeframe
  • Excellent organizational and time management skills
Qualifications
  • Requires Bachelor's degree (4 years) or higher from an accredited course of study, in engineering, engineering technology, computer science or technical field with relevant experience
  • Requires at least three (3) years experiences in a medical device or highly regulated industry
  • Experience working in a manufacturing environment preferred
  • Experience with implementing and maintaining a Manufacturing Execution System / eDHR preferred
  • Experience with Change Management, Computer System Validation, and HP ALM preferred

Terumo is an equal opportunity employer and welcomes applications from diverse candidates.



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