QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
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Leads end-to-end execution of packaging and labeling changes required for EU MDR (European Medical Device Regulation) compliance.
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Accountable for ensuring on-time delivery, cross-functional execution, and strong Business Unit alignment while managing packaging updates such as IFUs, cartons, and labeling changes.
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Ensures all changes are implemented compliantly with no disruption to manufacturing or supply.
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1. Project Execution & Timeline Management
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Lead full lifecycle project management for EU MDR packaging and labeling changes
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Develop and maintain integrated project plans, including milestones and critical paths
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Business Unit & Stakeholder Management
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Serve as the primary liaison with Business Units
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Provide executive-level communication and updates
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Coordinate cross-functional teams across Quality, Regulatory, Operations, Supply Chain, Engineering, and IT
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Packaging & Labeling Implementation Oversight
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Lead implementation of IFUs, cartons, labeling, and artwork changes
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Ensure compliance with EU MDR and internal quality requirements
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Manage change control using Agile (Oracle PLM), SAP ERP, and Factory Works MES
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Ensure data accuracy and system synchronization
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Drive timely approvals and change closure
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Ensure compliance with EU MDR, FDA, and ISO 13485
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Maintain audit-ready documentation
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Support audits and inspections
Qualifications:
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Bachelor’s degree in engineering or related area.
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Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
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Agile / Hybrid Methodologies (Scrum, Kanban, SAFe exposure) Data & Reporting Tools (Power BI, dashboards, KPI tracking) Resource Optimization (capacity planning, utilization analysis)
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Project Planning & Scheduling (WBS, critical path, milestones, dependencies) Risk & Issue Management (risk registers, mitigation plans, escalation) Cost & Scope Control (budget tracking, change control, earned value basics
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PMP certification or equivalent
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Experience in medical device packaging compliance
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Experience in regulatory remediation initiatives
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Agile (Oracle PLM) or similar change control systems
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SAP ERP
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MES systems (Factory Works preferred)
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Understanding of packaging and labeling processes
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Working Shift: 1st shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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