Lead QA Systems Validation Engineer

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences,diagnosticsand biotechnology

At Cepheid, one of15+ operating companies, our work saves lives-andwe'reall united by a shared commitment to innovate for tangible impact.

You'llthrive 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'llget 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 thewhich makes everything possible.

The Lead QA Systems Validation Engineer will lead quality systems activities related to multiple software development projects, with a focus on design control and risk management in accordance with FDA and ISO regulations. This position contributes to the completion of milestones associated with software projects and activities using existing procedures.

This position is part of the Product Software Quality department and willbeanon-siterolein Bengaluru, India. At Product Software Quality, our vision is to deliver Quality products to our customers.

In this role, you will have the opportunity to:

• Define design validation strategies and lead validation execution activities at the system level

• Collaborate with project core team to engage internal and external users during design validation activities

• Collaborate with the project core team to identify safety and security risks through a formal risk assessment per SOPs

• Work closely with Regulatory Affairs to develop a package for software 510(k) and PMA submissions

• Continuously improve standard operating procedures to meet regulatory compliance requirement changes within design controls and product security

• Mentor and manage validation execution team schedules per project timelines

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, IEC-62304, ISO-14971 and ISO-13485 regulations

• Proven history working in a wet lab.

• 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 in molecular diagnostics.

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.

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.

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