FIND_THE_RIGHTJOB.
Arroyo, Puerto Rico
Support the design and testing of new products.
Ensure that everything functions well and meets quality standards.
Identify and prevent potential problems (especially risks, defects, and inspection issues).
Ensure the product can be manufactured efficiently and safely.
Support validations (process, tool, and equipment testing)
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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