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Ecocareers · 21 hours ago

MES Quality Engineer

Elkton, MD

Full-time

Onsite

Mid Level

3+ years exp

Confidential company is seeking a MES Quality Engineer II to work closely with IT, Operations, Validation, and Engineering teams to ensure compliant and timely implementation of MES projects. The role involves supporting production, driving continuous improvement, and ensuring compliance with quality policies and procedures.

Staffing & Recruiting

Responsibilities

Act as an integrated MES team member to support new MES deployments, sustaining, and optimization projects

Demonstrates understanding and application of engineering principles on cross-functional 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

Applies 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

Perform other job-related duties

Qualification

Manufacturing Execution SystemComputer System ValidationQuality System RegulationsChange ManagementEDHRCommunicationProblem-solvingDetail orientedSelf-motivatedOrganizational skills

Required

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

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