Quality Assurance Scientist Ii

2 weeks ago

Washington, United States Beckman Coulter Diagnostics Full time

**Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.**

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 Quality Assurance Scientist II for Beckman Coulter Diagnostics is responsible for participating in complaint handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience. These activities will include receiving, documenting, evaluating, and managing all complaints and other Customer Feedback (CF).

This position is part of the Post Market Surveillance located at Miami, Florida and will be hybrid. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Post Market Surveillance Quality team and report to the Post Market Surveillance Quality Manager responsible for Hematology Complaints Handling. If you thrive in a multifunctional, fast paced, supporting role and want to work to build a world-class Quality Assurance organization—read on.

**In this role, you will have the opportunity to**:

- Receive and process escalated products complaints and customer feedback from internal and external customers in a manner consistent with all laws and regulations for medical devices and assess complaint for determination of adverse event reporting and/or vigilance reporting.
- Contact customer with findings of complaint investigation as needed, and document outcome of the complaint investigation and write a customer letter as required.
- Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action, and/or Stop Shipment activities.
- Communicate effectively within project teams and departments. Ensure completion of key deliverables.
- Analyze complaints, instrument and patient data to identify issues, patterns and trends.

**The essential requirements of the job include**:

- Bachelor’s degree with 5+ years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience or Master’s degree with 3+ years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience or Doctoral degree with 1 year in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience
- Knowledge of domestic and international quality systems and other standards such as FDA, EU 2017/745, ISO 13485, ISO 14971 or other applicable standards and regulations.
- Ability to support several projects simultaneously
- Proficient in Microsoft Words, Excel spreadsheets, PowerPoint.

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

- Practical experience in Hematology and/or clinical lab setting
- Medical Technologist /Clinical Laboratory background
- Ability to influence decisions across functions

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

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