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 15+ operating companies, our work saves livesand 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 which makes everything possible.
The
Manager, Systems Design Control Quality provides technical and managerial guidance to highly skilled individual contributors and reinforces technical direction of the group for Systems and Instrument quality. Apply knowledge of design control principles and product evaluation techniques to positively influence the development of Instrument products and to ensure they are developed and manufactured in accordance with regulatory and customer requirements. This position interacts with personnel at all levels and departments in the company to ensure full compliance with all product requirements and specifications to meet both company and customer expectations.
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
- Develop and implement Quality Systems processes to support medical device development including system level integration
- Build and grow a high-performance team through recruiting, coaching, engagement and performance management
- Provide and analyze quality metrics for customer complaints
- Participate in internal and external audits as a subject matter expert for Systems Quality
- Provide guidance to ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management and design review
- Develop risk analysis standards and lead risk analysis teams at appropriate points during product development life cycle
- Lead and coordinate communications with internal customers to ensure requirements are understood and component/product performance is appropriately managed
The Essential Requirements Of The Job Include
- BA/BS degree in Computer Science or related field with 12+ years of experience in FDA, ISO, or other regulated industry
- Minimum 3 years of managerial experience overseeing technical teams in regulated product management environments
- Advanced knowledge and hands-on experience with QSR and ISO-13485 regulatory frameworks
- Completion of multiple major product development projects with full release cycles in FDA/ ISO-regulated settings
- Working knowledge of end-to-end product development lifecycle processes, including design controls and verification/ validation activities
- Experience leading formal risk assessment activities using tools such as FMEA within regulated product development
- Demonstrated ability to manage compliance-driven technical deliverables across cross-functional engineering and quality teams
It would be a plus if you also possess previous experience in:
- Experience in Agile scrum software development methodology
- Experience with applications such as complaint tracking, automated testing applications, web-based applications, requirements management systems are a plus.
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.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) 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 Company's sole discretion, consistent with the law.
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.
