In this role, you will have the opportunity to :
- 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.
The essential requirements of the job include :
- 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
It would be a plus if you also possess previous experience in :
- ISO13485, 9001 standards.
- FDA regulated environment experience.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology.
We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.
Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.
Please contact us at redacted to request accommodation.
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