Senior Quality Assurance
Danaher
- USA
- Permanent
- Full-time
- 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.
- 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 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.