Senior Analyst - Design Quality Assurance
Senior Analyst - Design Quality Assurance
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Senior Analyst Design Quality Assurance
Job Location: Bengaluru Karnataka India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level:
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 2900 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:
For more information visit
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.
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.
- 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.
- CAPA Risk Management process.
- System level core team QA support including hardware software reagent and the combination.
- FDA Audit preparation and undergone FDA audit.
For more information visit
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.
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Employment Type
Full Time
Key Skills
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