Quality Engineer - Process Development
On-site · Dorado, Dorado, Puerto Rico
Job Summary
Quality Engineer - Process Development: support process and equipment validation activities (IQ, OQ, PQ), develop Master validation plans for new processes/products, review validation protocols/reports, assist other functional areas during validation, collaborate to qualify new processes, assist on statistical sampling plans, design in-process/receiving quality systems, define gages/tools/equipment for test methods, identify and control manufacturing defects, participate in root-cause/corrective actions, develop risk analyses and FMEAs, develop Process Monitoring Systems, lead process improvement to capture quality metrics, and support creation of Quality Tools and Training Materials; operates within pharmaceutical/medical device manufacturing quality systems.
Required Qualifications
- Bachelor’s Degree in Engineering
- 5 years of experience in the review and approval of life cycle validation documentation in the regulated industry
- Bilingual: Spanish and English
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