Danaher Corporation Sr Quality Assurance Scientist - Post Market Surveillance in Miami, Florida
Danaher Company Description
At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates’ careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.
We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.
Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences.
The Senior Quality Assurance (QA) Scientist for Post Market Surveillance (PMS) provides primary support to operations pertaining to proactive and systematic post market monitoring and surveillance process within the Global Business Unit (Hematology, Flow Cytometry & Urinalysis) product lines. The Senior QA Scientist (PMS) will support the PMS Manager in establishing and maintaining a systematic PMS System to comply with Post Market Surveillance Regulatory expectations for medical devices. The roles and responsibilities of Senior PMS analyst includes the following:
- Actively collaborate with cross-functional key stakeholders (Commercial Organization, Design & Development, Risk Management, Manufacturing, Supply Chain, Reliability, Pre-Market Quality/Regulatory, Clinical/Medical, and Marketing) in support of post market surveillance plan and report creation to assess the safety, effectiveness and performance of our regulated products/devices
- Responsible for obtaining data from multiple sources including but not limited to Complaints, Adverse Events, Recalls, Risk Management, CAPAs, Non-conformances, Validations, Literature) and perform the required analysis in applicable data analysis tools (Excel, Minitab, Access or similar applications); utilize public databases for obtaining post market data on competing products for comparative analysis. Responsible for ensuring traceability, reproducibility and consistency of the results generated
- Responsible for reviewing data analysis with the PMS Manager to detect emerging trends of such issues that may require action and escalation to Senior Leadership and BU partners. Work closely with PMS Manager to continually seek to identify new feeder systems to effectively monitor product performance after launch
- Responsible for compiling data and preparing reports at periodic intervals as required by regulations
- Support PMS Manager to partner with product functional areas to ensure that PMS output is fed back into R&D, Design Quality, Supplier Quality, CAPA Board and Marketing where applicable to achieve a closed-loop process
- Maintain professional and technical knowledge and continually update knowledge on competing product technologies in the Market by reviewing publications
- Maintain current knowledge of global regulations impacting PMS. Apply knowledge to develop and optimize processes, and suggest improvement to current processes as needed
* Bachelor’s degree in scientific discipline * 5 years of relevant Quality/Regulatory Affairs experience or Master’s degree in Science and 3 years of relevant Quality/Regulatory Affairs experience or doctoral degree in field with 0-2 years or relevant experience
Experience Desired: * Demonstrated knowledge of BEC products (Hematology, Flow Cytometry, and Urinalysis) or related medical devices * Experience with managing and prioritizing multiple projects * Demonstrated experience with use of data analysis and visual analysis Tools; experience applying data analysis concepts * Experience participating on cross functional teams * FDA regulated environment experience is strongly recommended * Experience with and knowledge of domestic and international quality
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: Beckman Coulter - Diagnostics
Job Function: Science
Primary Location: North America-North America-United States-FL-Miami
Req ID: BEC011184