Post Market Surveillance Reporting and CAPA Management/Coordination

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At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. 

The Senior Quality Assurance Scientist for Beckman Coulter Diagnostics is responsible Post Market Surveillance Reporting.

This position is part of the Quality and Regulatory Organization located in Brea, CA and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the CAPA/PMS/MasterControl Team and report to the Sr. Manager of CAPA/PMS/MasterControl responsible for Corrective Action Preventive Action. If you thrive in a multifunctional, fast paced, supporting role and want to work to build a world-class quality organization—read on.

In this role, you will have the opportunity to:

• 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.

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. 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

It would be a plus if you also possess experience in:

• ISO13485 and ISO9001 standards

• Post market surveillance experience

The salary range for this role is 95,000.00 - 115,000.00 USD Annual. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

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

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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