Katalyst CRO ยท 1 day ago
MES Quality Engineer
Elkton, MD
Contract
Onsite
Mid Level
3+ years expKatalyst Healthcares & Life Sciences is seeking a MES Quality Engineer II to work closely with IT, Operations, Validation, and Engineering teams. The role focuses on ensuring compliant and timely implementation of MES projects, supporting production, and driving continuous improvement.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Required
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
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
Preferred
Experience working in a manufacturing environment
Experience with implementing and maintaining a Manufacturing Execution System / eDHR
Experience with Change Management, Computer System Validation, and Client ALM
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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