Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you’ll help drive our vision of accelerating answers—and our commitment to excellence.
Beckman Coulter Life Sciences is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
Do you want to work in Global Dev QA team? Do you enjoy Core team QA supporting NPDs and Design changes? Then read on!
We are currently seeking a Senior Analyst - Design Quality Assurance who will be responsible for Quality assurance of design control, monitor of design control, coordinate and track of design defect, and Drive quality improvement project from design control.
In this role, you will be responsible for:
Ensure design control process compliance throughout whole product lifecycle.
Guide and overall support product design control process and risk management process.
Review and Approve DHF.
Establish, maintain, continual improve QMS and ensure fully meet regulation requirement.
Monitor design control process performance with data analysis.
Lead quality improvement project to improve process effectiveness and ensure product safety.
Offer quality training.
The required qualifications for the job include:
Bachelor’s degree in field with OR Master’s degree (Educational background in biotechnology, medicine, laboratory science, biology, immunology or pharmacy related majors)
At least 7+ Years experience in reagent development, test or quality assurance experience supporting new project launch or design changes. Atleast 3 years experience in reagent design and development quality assurance role.
Understand the quality control point of in vitro diagnostic reagents design and development, understand the principles and testing methods of the product.
Be familiar with ISO 13485, GMP and relative quality management system regarding to IVD product design control.
Be familiar with quality tool usage supporting quality data analysis.
Be fluent in English speaking.
It would be a plus if you also possess previous experience in:
CAPA, Risk Management process.
System level core team QA support including hardware, software, reagent, and the combination.
FDA Audit preparation and undergone FDA audit.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.
For more information, visit www.danaher.com.
At Danaher, 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.