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Principal Quality Engineer

Company: Danaher Corporation
Location: Fremont
Posted on: April 4, 2021

Job Description:

Danaher Corporation Principal Quality Engineer in Fremont , California Do you want to support products you feel passionate about? SCIEX is seeking a Principal Quality Engineer to work in our Fremont, CA office supporting New Product Development and to be the site Quality System Lead. As an individual contributor you will partner with Site Leadership, the R&D Team, and the Global QA/RA Team to drive end to end product quality for our analytical solutions supporting all stages of biopharmaceutical development and manufacturing. Major Responsibilities Provides quality leadership for new product development projects and sustaining support through the complete product life cycle. Work cross-functionally with R&D, Operations, Supplier Quality and others to drive continuous product quality improvements. Responsible for maintenance and continuous improvement of the Quality System at site in accordance with ISO 9001. Responsible for hosting and ensuring site compliance during internal and external audits, working closely with the SCIEX Global QMS Manager. Develop and maintain quality system metrics to ensure continuous development. Education, Background, and Skills BS degree in Engineering or relevant scientific discipline Minimum of 10 years of quality engineering experience in the Medical Device, Pharmaceutical or Biotechnology industry Demonstrated history with new product development through the complete life cycle Experience understanding and applying ISO 9001, knowledge of ISO 13485 a plus. Thorough knowledge of quality systems, validation principles for product and manufacturing processes, engineering design fundamentals Working competency of statistical programs (i.e., Minitab, SAS, etc.) Certified Quality Engineer (CQE) preferred Diversity and InclusionAt Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page -- Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. #LI-LW1 Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Keywords: Danaher Corporation, Fremont , Principal Quality Engineer, Engineering , Fremont, California

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