Senior Quality Assurance Engineer
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 supporting the development and sustainment of Medical Device manufacturing operations by applying a rigorous, riskbased approach that ensures compliance with corporate policies, 21 CFR 820, ISO 13485, and other relevant regulatory standards. In this role, you will play a pivotal part in supporting production development, enhancing automation equipment performance, and elevating manufacturing quality controls to support fast paced, highyield operation. These efforts enhance manufacturing reliability, strengthen process capability, and provide strong quality leadership that drives the continuous improvement. This position reports to the Sr Manager of Quality Engineering and is part of the Quality Engineering Team located in Newark, CA, and will be an on-site role. In this role, you will have the opportunity to: Lead daily quality engineering support for medical device manufacturing operations, including oversight of critical processes, equipment performance, and inline quality inspections. Serve as the primary Quality Engineering representative on crossfunctional teams for automation equipment and manufacturing process development/sustainment activities. Drive risk assessment activities, including process FMEAs, to assistmanufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution. Develop and review project documentation such as quality plan, validation master plan, risk management plan, quality control plan and IQ/OQ/PQ protocols and reports to ensure full compliance with regulatory requirements and Cepheid Quality Management System. Address nonconformities and deviations by performing risk assessments, identifying root causes, conducting failure mode analysis, defining disposition, and supporting effective corrective and preventive actions to prevent recurrence.
The essential requirements of the job include: BS degree in mechanical, industrial, biomedical engineering, or related field with 5+ years of quality engineering experience or masters degree with 3+ years of quality experience. Strong understanding of ISO 13485, 21 CFR 820, and GMP requirements.
Proven experience in NPI Quality and working with complex systems, including design verification and validation, part and process qualification, and the qualification and validation of automation equipment.
Travel, Motor Vehicle Record & Physical/Environment Requirements: It would be a plus if you also possess previous experience in: Experience in medical device manufacturing or biomedical Experience in biochip and post-fab waferprocessing operations Certified Quality Engineer and/or Lead Auditor certification
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job. 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 flexible time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. The annual salary range OR the hourly range for this role is $116,000-159,500. 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 Company's sole discretion unless and until paid and may be modified at the Companys sole discretion, consistent with the law. #LI-LCS 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 www.danaher.com. 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. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.
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