Job Summary: The Manufacturing Execution System (MES) Quality Engineer II position will work closely with the IT, Operations, Validation, and Engineering, teams to ensure that projects (new MES deployments, sustaining, and/or optimization) related to MES are implemented compliantly and in a timely manner. This role will support production to drive continuous improvement. The position will also ensure compliance to Terumo's quality policy, develop requirements, revise/create procedures, develop validation test cases, and maintain the integrity of the electronic device history record (eDHR). Job Details: Act as an integrated MES team member to support new MES deployments, sustaining, and optimization projectsDemonstrates understanding and application of engineering principles on cross-functional projectsDevelop and/or revise MES requirements documentation, procedures, control plans, PFMEAs, and training materialsMaintain the compliance of the MES, the integrity of its validated state, and the eDHRProactively identifies requirements gaps, investigates, and implements best-in-class Quality Engineering practices and solutionsApplies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues related to MESDevelop MES validation test cases and support Software Verification & Validation activitiesSupport the Elkton, MD site as a subject matter expert (SME) related to MES and the integration with Product Life Cycle ManagementDevelop training strategy plans and support MES team to deliver training on MES processesMay need to work across shifts during some phases of MES deploymentsPerform other job-related duties Position Requirements: Knowledge, Skills and Abilities (KSAs) A' . 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/EECA' . Excellent communication skills; verbal and writtenA' . Ability to work as a team member on cross-functional teams and with employees across all levels within the facilityA' . Excellent computer skills and working knowledge of Microsoft Office SuiteA' . Problem-solving and critical thinkingA' . Detail and results-oriented A' . Self-motivated and driven A' . Ability to multitask, prioritize, and provide deliverables within the required timeframeA' . Excellent organizational and time management skills Background Experiences A' . 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 experienceA' . Requires at least three (3) years experiences in a medical device or highly regulated industryA' . Experience working in a manufacturing environment preferredA' . Experience with implementing and maintaining a Manufacturing Execution System / eDHR preferredA' . Experience with Change Management, Computer System Validation, and HP ALM preferred