Post Market Surveillance Reporting and CAPA Management/Coordination

Wondering whats within Beckman Coulter Diagnostics? Take a closer look.At first glance, youll see that for more than 80 years weve 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. Were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and youll 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, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds 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 organizationread 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 experienceIt would be a plus if you also possess experience in:+ ISO13485 and ISO9001 standards+ Post market surveillance experienceThe 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 Companys sole discretion, consistent with the law.#LI-GC1At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrows 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 whats 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 (https://www.dol.gov/agencies/ofccp/posters) .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 applyassistance@danaher.com to request accommodation.