Job Description
We are the people who give possibilities purpose 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.
Job Description Position Summary:
The 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. Essential / Key Job Responsibilities:
Support the development, implementation, and ongoing maintenance of Quality Management System (QMS) processes to ensure full compliance with FDA 21 CFR
820 and ISO 13485
requirements Maintain and control documents used in the manufacturing of medical devices, including updating and distributing procedures Assist in managing electronic quality management system Maintain and control quality records for the site Administer the site training program by ensuring required training is assigned and training records are retained Perform comprehensive review of device history records (DHRs) and other relevant production documentation to ensure accuracy, completeness, and compliance with specifications and procedures Verify quality inspection results meet acceptance criteria Generate and approve product release documentation Support the customer complaints process, including complaint intake, evaluation, and reporting Analyze complaint data and report trends for significant complaint issues Support product risk management process Lead Corrective and Preventive Action investigations, action implementation, and effectiveness checks Conduct environmental monitoring and trend data Investigate non-conformances and execute dispositions Perform software validations for QMS impacting software Participate in the site's internal and external audits Monitor quality system performance by compiling and presenting quality process performance data Coordinate and conduct information and training sessions, as necessary Identify and suggest continuous improvements to the quality management system Other duties and projects, as assigned Knowledge, Education, and Skills Required:
Bachelor's Degree in engineering or related field Working knowledge and/or experience in a regulated industry. FDA and medical device experience - preferred Knowledgeable of FDA/ISO applicable guidance, regulations, and standards, including ISO 13485
- preferred Strong attention to detail and excellent organizational skills Able to work proactively and independently Able to multi-task and efficient in time management Excellent verbal and written communication skills Able to work in a team environment Proficient in Excel, Word, and other desktop/general business systems 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 supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers . 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. Required Skills Optional Skills . Primary Work Location USA TX - San Antonio - Sebastian Place Additional Locations Work Shift
