Design Quality Engineer III

Skip to main contentWe use cookies and other tracking technologies to assist with navigation, improve our products and services, assist with our marketing efforts, and provide content from third parties. By continuing to use this site you agree to our use of cookies in accordance with our privacy policy. Manage third-party cookie preferences hereDeclineAccept CookiesEnglishSign InDesign Quality Engineer III page is loadedDesign Quality Engineer IIIApplyremote typeIn-OfficelocationsUSA CA - San Diego Bldg A&Btime typeFull timeposted onPosted 19 Days Agojob requisition idR-549002 We are the people who give possibilities purposeBD 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. Job DescriptionJob Responsibilities:Act as the Quality core team member for sustaining engineering projects.Participate in design control activities, including design reviews, risk management, and verification and validation planning and execution.Support the development and maintenance of design and development files (DDFs) to ensure compliance with internal procedures and external regulations (e.g., FDA, ISO 13485).Perform and/or review risk management activities, including Hazard Analysis, FMEA (Failure Mode and Effects Analysis), and risk-benefit analysis, ensuring appropriate risk mitigation strategies are identified and implemented.Provide quality engineering support for CAPA activities, including performing investigations and implementation of actions, and executing verification of effectiveness (VOE) to ensure solutions are sustained and compliant with FDA/ISO and internal requirements.Author field issue assessments using post-market data, complaint investigations, and risk analyses in compliance with 21 CFR 806 and EU MDR.Participate in internal and external audits (e.g., FDA, Notified Body).Mentor junior quality engineers and provide technical guidance on design quality principles and practices.Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, Marketing) to ensure quality objectives are met.Develop and implement quality plans, procedures, and work instructions to enhance the effectiveness of the quality management system.Contribute to continuous improvement initiatives within the quality organization, identifying opportunities for process optimization.Job Qualifications:Minimum RequirementsBachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Industrial, or related field)5–7 years of experience in Design Quality Engineering within the medical device industryStrong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485Hands-on experience with design controls and risk management (ISO 14971)Basic understanding of corrections/removals processes (21 CFR Part 806)Strong analytical and problem-solving skills with the ability to investigate complex issuesEffective written and verbal communication skillsAbility to work both independently and collaboratively in a fast-paced environmentPreferred QualificationsMaster’s degree in EngineeringExperience with statistical software (e.g., Minitab, JMP)ASQ certification (CQE, CRE, CMQ/OE)Why Join Us?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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration...