Senior Quality Engineer
Senior Quality Engineer
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$ 111100 - 135500
1 Vacancy
Job 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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 youll 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 worlds most complex health challenges. Together we bring MORE change to the world.
Learn about the Danaher Business System which makes everything possible.
The Senior Quality Engineer is responsible for driving manufacturing and product lifecycle quality by implementing a risk-based approach to ensure compliance with corporate policies 21 CFR 820 ISO 13485 and other regulatory standards while championing continuous improvement. You will play a pivotal role in New Product Introduction (NPI) and Change Control processes ensuring accurate and complete quality deliverables during design transfer to manufacturing. This includes reviewing change orders and deviations to confirm clear well-documented rationales and comprehensive impact assessments for significant changes. By developing robust qualification strategies you will proactively mitigate risks associated with design and process modifications enhancing product reliability and supporting innovative product development.
This position reports to the Sr Manager of Quality Engineering and is part of the Quality Engineering team located in Sunnyvale CA and will be an on-site role.
In this role you will have the opportunity to:
Lead quality engineering efforts for PCR-based assay development including analytical method validation reagent qualification and system-level performance verification.
Serve as the primary Quality Engineering representative on cross-functional teams for new product introduction and manufacturing sustainment providing strategic input on design control risk management and quality compliance.
Drive risk assessment activities including safety design and process FMEA with a focus on assay sensitivity reagent compatibility specificity and robustness.
Create project-specific documents such as validation master plans risk management plans and qualification protocols to meet compliance requirements.
Address nonconformities and deviations through risk assessment root cause identification failure mode analysis and proposing disposition.
The essential requirements of the job include:
BS degree in chemistry molecular biology biomedical engineering or related field with 5 years of quality engineering experience masters degree with 3 years experience OR Doctoral degree with 1 year(s) experience.
Proven experience in working with the assay development including method validation troubleshooting performance characterization and continuous process improvement for biological assays and processes.
Experienced in NPI Quality for complex systems including design verification and validation part qualification and test method validation.
Experience in the application of process control plans statistical process control and quality system regulations (e.g. 21 CFR 820 ISO 13485).
Demonstrated ability to lead cross-functional teams and guide product development from concept to commercialization.
It would be a plus if you also possess previous experience in:
Experience in biomedical or medical device manufacturing
Certified Quality Engineer and/or Lead Auditor certification
Cepheid a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is $. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.
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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
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Join our winning team today. Together well accelerate the real-life impact of tomorrows 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 .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law. 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.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
Required Experience:
Senior IC
Employment Type
Full-Time
