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

4 weeks ago


Brea, California, United States Beckman Coulter Full time
Job Summary

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.

This job is also eligible for bonus/incentive pay.



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