Staff Quality Engineer

Job DescriptionWe are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.Job Description Summary: Supports quality activities for the development, implementation, and ongoing support of IVD reagent products and devices, and their related processes, equipment, and software. Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as design and process validation, measurement systems analysis, equipment and software validation, root cause analysis, FMEAs, risk mitigation, DOE/other process improvement tools, sampling and control plans. Applies technical principles, theories, concepts, techniques and quality sciences / tools. Follows company procedures and makes procedural updates. Demonstrates working knowledge and application of applicable regulatory, Corporate and/or Unit requirements. Is a Core Team member, or extended team member representing Site Quality on new product development projects and a team member for sustaining engineering projects. Acts as Quality Assurance reviewer/approver or author for documentation such as protocols and reports, deviations, and design history files. Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, and waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement projects. Supports appropriate CAPA activities to accomplish internal/external objectives. Supports process, Test Method, Equipment, and Software Validations (IQ, OQ, PQ). Design Control (Both New Product Development and Sustaining Processes as applicable). Teach and assist associates in Quality system concepts and documentation. Hybrid in-office/remote position.Qualifications: Master's degree in Biomedical Engineering, Chemical Engineering, or related and two (2) years of work experience in the job offered or related occupation in which the required experience was gained. In lieu of a Master's degree in Biomedical Engineering, Chemical Engineering, or related and two (2) years of work experience in the job offered or related occupation in which the required experience was gained, employer will also accept a Bachelor's degree in Biomedical Engineering, Chemical Engineering, or related and five (5) years of work experience in the job offered or related occupation in which the required experience was gained. Must also have demonstrated experience in the following: Process Validation; Biological or Mechanical scientific concepts; Regulations (FDA 21 CFR 820 and ISO 9001); Process and equipment validation (IQ, OQ, and PQ); Test method or software validation; and Minitab or other statistical software, MS Excel, and MS Word.Salary offered for the position is: $153,000.00 - $208,900.00/year.Primary Work Location: 155 McCarthy Blvd., Milpitas, CA 95035. Hybrid in-office/remote position.Additional Locations: N/A Work Shift: Not SpecifiedTo apply mail resume to Becton, Dickinson and Company, Attn: BDHR – DT, 3750 Torrey View Ct, San Diego, CA 92130. OR submit a resume to OR submit a resume to Must reference Job Title & Job Code: R-521155.For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.