AQE Engineer
Becton Dickinson & Co
BD seeks an experienced AQE Engineer to support quality, validation, and continuous improvement within medical device manufacturing operations in Puerto Rico. The role involves leading equipment and process validations, conducting quality investigations, and ensuring regulatory compliance in a cGMP environment.
Responsibilities
- Lead and execute equipment and process validations including IQ, OQ, and PQ protocols
- Conduct quality investigations, root cause analysis, and corrective action implementation
- Support supplier quality activities, vendor audits, and regulatory compliance initiatives
- Analyze quality trends and drive continuous improvement projects
- Partner with cross-functional teams to resolve quality concerns and enhance processes
Requirements
- Bachelor's degree in Engineering
- 3-5 years of engineering experience
- Strong experience with IQ, OQ, and PQ validation protocols
- Knowledge of cGMP, ISO standards, and regulated manufacturing
- Bilingual proficiency in Spanish and English
- Strong analytical and problem-solving skills
- Medical device manufacturing experience preferred
Vacancy posted a month ago
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