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Manufacturing Process Specialist
hace 2 semanas
Job Description: As a Manufacturing Process Specialist at Theragenics Costa Rica Ltd., you will play a crucial role in implementing improvement opportunities in our processes to ensure production goals are achieved. Collaborate with Operations to identify areas for improvement and develop strategies to enhance process capability.
Main Responsibilities:
- SUPPORT PRODUCTION AREA IN TROUBLESHOOTING PROCESS AND DELIVER TIMELY SOLUTIONS FOR PRODUCT DEVELOPMENT.
- RESPOND QUICKLY TO THE OCCURRENCE OF DEFECTS AND UNPLANNED PRODUCTION DOWNTIMES DUE TO EQUIPMENT FAILURES, PROCESS ISSUES.
- LEAD A TEAM TO INVESTIGATE THE ROOT CAUSES OF PROCESS PROBLEMS AND IMPLEMENT CORRECTIVE ACTIONS.
- DEVELOP PROCEDURES TO ENSURE PRODUCT QUALITY/PROCESS CAPABILITY AND REDUCE PROCESS VARIABILITY ENSURING CONSISTENCY IN MFG EXECUTION.
Requirements:
- Bachelor's in Engineering (Mechanical Chemical Industrial prefer).
- Bilingual: English and Spanish B2 level minimum.
- Postgraduate degree preferred.
- MINIMUM 7 YEARS IN A MEDICAL DEVICE MANUFACTURING ENVIRONMENT.
- EXPERIENCE WITH GMPs AND ISO 13485 A PLUS.
- VALIDATION EXECUTION EXPERIENCE, PROCESS CHARACTERIZATION, IQ, OQ, PQ DESIRABLE TRANSFER EXPERIENCE.
