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.Position SummaryThe Quality Engineer will be responsible for executing and maintaining elements of the Quality Management System (QMS). The Quality Engineer will work on-site with multi-functional teams to implement, execute, maintain, and monitor the performance of quality system processes to support department and site goals.Key Job ResponsibilitiesSupport the development, implementation, and ongoing maintenance of Quality Management System (QMS) processes to ensure full compliance with FDA 21 CFR 820 and ISO 13485 requirementsMaintain and control documents used in the manufacturing of medical devices, including updating and distributing proceduresAssist in managing electronic quality management systemMaintain and control quality records for the siteAdminister the site training program by ensuring required training is assigned and training records are retainedPerform comprehensive review of device history records (DHRs) and other relevant production documentation to ensure accuracy, completeness, and compliance with specifications and proceduresVerify quality inspection results meet acceptance criteriaGenerate and approve product release documentationSupport the customer complaints process, including complaint intake, evaluation, and reportingAnalyze complaint data and report trends for significant complaint issuesSupport product risk management processLead Corrective and Preventive Action investigations, action implementation, and effectiveness checksConduct environmental monitoring and trend dataInvestigate non-conformances and execute dispositionsPerform software validations for QMS impacting softwareParticipate in the site's internal and external auditsMonitor quality system performance by compiling and presenting quality process performance dataCoordinate and conduct information and training sessions, as necessaryIdentify and suggest continuous improvements to the quality management systemOther duties and projects, as assignedQualifications and SkillsBachelor's Degree in engineering or related fieldWorking knowledge and/or experience in a regulated industry. FDA and medical device experience - preferredKnowledgeable of FDA/ISO applicable guidance, regulations, and standards, including ISO 13485 - preferredStrong attention to detail and excellent organizational skillsAble to work proactively and independentlyAble to multi-task and efficient in time managementExcellent verbal and written communication skillsAble to work in a team environmentProficient in Excel, Word, and other desktop/general business systemsLocationUSA TX - San Antonio - Sebastian PlaceWhy 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 supports your learning, your progress, and your success.Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action 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.#J-18808-Ljbffr