Danaher Corporation Staff Quality Assurance Engineer in San Jose, California
Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you’ll help drive our vision of accelerating answers—and our commitment to excellence.
Beckman Coulter Life Sciences is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
The Staff Quality Assurance Engineer will represent quality assurance on development core teams, current business project teams or product improvement projects for Beckman Coulter Life Science. Products supported include laboratory automation, centrifugation, genomics, flow cytometry, particle counting and particle characterization systems. Candidates will apply understanding of quality systems, design controls, industry standards and lifecycle processes to product hardware and software including embedded, product and cloud environments.
• Assures compliant process conformance and complete product documentation, inclusive of Design History, Product, Process Service documentation, supporting successful and compliant standard and custom product realization within the Beckman Coulter quality system.• Partners engineering to ensure product and service conformance to requirements of ISO 9001, 13485, 21 CFR 820 and/or 27001/SOC©2 with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls, Product Privacy and Security. • Coaches teams with application of product software lifecycle, verification and validation requirements for FDA device software guidance and IEC62304 standards. • Guides application of GxP non-product software development and validation under industry standards and regulations including GAMP, 21 CFR Part 11. • Aware of current industry standards and regulations and how they relate to internal policies and procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance.• Able to identify, develop and execute quality system, product and process improvements including drive change cross functionally across multi-site operations.
• BS Degree in electrical, mechanical, computer or other engineering discipline; science or related field; or equivalent experience required.• MS Degree or higher preferred• BS+5 or MS+3 years’ experience in product development, manufacturing and / or quality in medical device, pharmaceutical, or related regulated field (e.g FDA, DoD, Aerospace, Automotive) • Certified Software or Quality Engineer (SQA) preferred and/or Auditor Certification desired
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
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 (https://www.dol.gov/agencies/ofccp/posters) .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 email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.