Senior Quality Assurance Scientist for Post Market Surveillance Reporting and CAPA Management

3 weeks ago


Brea, California, United States Beckman Coulter Full time
About the Role

We are seeking a highly skilled Senior Quality Assurance Scientist to join our team in Brea, CA. As a key member of our Quality and Regulatory Organization, you will be responsible for Post Market Surveillance Reporting and CAPA Management.

Key Responsibilities
  • Perform Evaluation of Documentation Management with a focus on Post Market Surveillance Reporting.
  • Lead Post Market Surveillance Reviews and write reports in a timely manner while working with multiple parties to drive results.
  • Review and approve Quality documentation.
  • CAPA Coordination/Management activities.
  • Drive process improvements and change by using/developing DBS skills.
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.
  • Should include experience in an FDA regulated environment.
  • 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.
  • CAPA experience.
Preferred Qualifications
  • ISO13485 and ISO9001 standards.
  • Post market surveillance experience.
What We Offer

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

About Us

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. We 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.



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