FIND_THE_RIGHTJOB.
Arroyo, Puerto Rico
Lead the team in the development of the project charter and management plan. Direct, manage, monitor, and control project. Evaluate tradeoffs within project.
Meet with project stakeholders to understand and refine project scope; review with manager for approval. Create detailed Work Breakdown Structure.
Develop and manage the detailed project Gantt chart. Analyze critical path and major workstreams.
Develop a risk management plan for the project. Identify, analyze and understand project risks, develop and monitor a risk response plan.
Required:
University degree in engineering (or similar).
Experience in regulated industries, such as medical devices or pharmaceuticals.
Understanding of manufacturing processes and quality tools such as FMEA (Failure Mode and Effects Analysis), CAPA (Corrective and Preventive Actions), PPAP (Production Part Approval Process), validations, and inspections.
Knowledge of standards such as ISO 13485 (quality standard for medical devices).
Advanced English communication skills
Desirable:
Experience with Process Flow Mapping (PFM) or process risk assessment.
Experience with non-conformity management.
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