Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cepheid, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Lead, Systems Quality Engineer is responsible to support design validation activities related to assay, instrument and software development with focus on design controls in accordance with FDA and ISO regulations.
This position is part of the Quality department and will be located in the India Development Center, Bengaluru, India. The Quality department collaborates with cross-functional business partners to ensure that customer needs and safety are met, government regulations and quality requirements are effectively monitored, measured, maintained and continuously improved.
In this role, you will have the opportunity to:
+ Participate in product development core teams as a quality representative to provide guidance on design control deliverables at system level
+ Define design validation strategies and oversee test architecture from system perspective
+ Perform impact analysis for the post market product design changes
+ Conduct safety risk analysis, participate in design and security risk analysis
+ Drive continuous improvements with changes in business needs, new and updated changes in guidelines from FDA and other regulatory agencies
+ Develop and maintain design control KPIs
+ Participate in internal and external audits as SME
The essential requirements of the job include:
+ BA/BS degree in any Science or Engineering field
+ 7+ years of working experience in regulated industry
+ Proficiency and working knowledge in Design controls, ISO-14971, ISO-60601, ISO-62366, ISO-13485, and IEC-63000 (RoHS) regulations
+ Proven history of working with complex projects in multiple release cycles
+ Experience in leading design validation activities and risk management activities
It would be a plus if you also possess previous experience in:
+ Quality Engineering certification from American society for quality (ASQ) or other qualifying organizations such as CRE, CQA
+ Experience working with software tools such as Agile, Complaint tracking, requirements management, defect tracking systems
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .
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 .
Operating Company: Cepheid
