MES Quality Engineer II
3 days ago
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- Collaborate with IT, Operations, Validation, and Engineering teams to implement MES projects compliantly and in a timely manner.
- Support production to drive continuous improvement and ensure compliance to quality policy.
- 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 identify requirements gaps, investigate, and implement 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.
- May need to work across shifts during some phases of MES deployments.
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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MES Quality Engineer II
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Elkton, Maryland, United States Terumo Medical Corporation Full timeJob SummaryThe MES Quality Engineer II position plays a critical role in ensuring the successful implementation of Manufacturing Execution System (MES) projects. This individual will work closely with cross-functional teams to ensure compliance and timely delivery of projects. The successful candidate will drive continuous improvement in production and...
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MES Quality Engineer II
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Elkton, Maryland, United States Terumo Medical Corporation Full time{"Job Title": "MES Quality Engineer II", "Job Summary": "We are seeking a highly skilled MES Quality Engineer II to join our team at Terumo Medical Corporation. As a key member of our Quality Assurance team, you will be responsible for ensuring the compliance of our Manufacturing Execution System (MES) with regulatory requirements and industry standards.Your...
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