Senior Quality Assurance

Permanent
  • International Noel Nawab Street, Los Alamitos CA 90720, USA

Job Details

Requirements

BS degree in Science/ Medical Technologist with a minimum 5+ years related experience or MS degree in field with 0-2 years of related experience. Detail oriented and strong organizational skillsDetail oriented and strong organizational skills. Highly effective communicator with the ability to influence and build trusted partnerships. Strong verbal and Writing skills, proficient with Microsoft Office. ISO13485, 9001 standards. FDA regulated environment experience.

Job Description

Perform Evaluation of Documentation Management with a focus on regulatory compliance against GDP and FDA regulations. Work with New Product Development on product transfers to Manufacturing. Review and approve Quality documentation which may include IQ/OQ/PQ’s, Process Validations and Design Changes. Partner with other reagent site leaders and work on Quality improvement projects and problem-solving events. Drive process improvements and change by using/developing DBS skills.

 
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