Quality Engineer
On-site · Dorado, Dorado, Puerto Rico
Job Summary
Quality Engineer responsible for QA activities around validation cycle documentation, change control, design control, and software validations in a regulated industry. Will oversee sterile packaging and labeling processes, perform ESQ and software validations, conduct inspections of labeling systems, and collaborate with cross-functional teams to identify and address quality issues. Requires experience with Windchill, CAPA, MES, and BMRAM; bilingual Spanish/English; and a Bachelor's degree in Engineering with 5 years of related experience.
Required Qualifications
- Bachelor’s Degree in Engineering
- 5 years of experience in review and approval of life cycle validation documentation in regulated industry
- Bilingual: Spanish and English
- Quality assurance focused on reviewing validation cycle documentation, quality systems, procedures, change control, and design control
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