QA Analyst Job at Beckman Coulter Life Sciences, Apply Now!
Beckman Coulter Life Sciences is hiring a Senior Analyst – Design QA in Bangalore, India. If you have expertise in quality assurance, reagent development, and regulatory compliance within the IVD industry, this is an exciting opportunity to join a global leader in life sciences.
About Beckman Coulter Life Sciences:
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.
Job Opening: Senior Analyst – Design Quality Assurance
Location: Bangalore, Karnataka, India
Category: Quality & Regulatory Affairs
Job Id: R1279151
Do you want to work in Global Dev QA team? Do you enjoy Core team QA supporting NPDs and
Design changes? Then read on!Responsibilities of Quality Assurance Senior Analyst:
- Ensure design control process compliance throughout the 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.
Qualifications:
- 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. At least 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.
Preferred Experience for Quality Assurance Senior Analyst:
- CAPA, Risk Management process.
- System level core team QA support including hardware, software, reagent, and the combination.
- FDA Audit preparation and undergone FDA audit.
Keywords: Beckman Coulter Life Sciences, Senior Analyst, Design Quality Assurance, Quality & Regulatory Affairs, Bangalore, Karnataka, India, reagent development, test, quality assurance, ISO 13485, GMP, FDA audit. QA Analyst Job at Beckman Coulter Life Sciences, Apply Now!
