Beckman Coulter Life Sciences mission is to empower those seeking answers to lifes 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, youll 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 and deliver training on quality process as and when required.
• Guide and overall support product risk management process.
• Review and Approve DHF.
• Establish, maintain, continual improve QMS and ensure fully meet regulation requirement.
• Monitor QMS process performance with data analysis and lead quality improvement project from system level.

The required qualifications for the job include:

• Bachelors degree in field with 5+ years exp. OR Masters degree in field with 3+ years exp.(Educational background in chemistry, biology, pharmaceuticals, and related fields.)
• At least 5 Years experience in reagent development, test or quality assurance experience supporting new project or design changes.
• 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.

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.

This job is eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical insurance 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. At 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. 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.