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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
Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) product design for manufacturability, customer complaints, assembly and test, inspection and validation throughout the development process.1.
Generate process/product quality information in the form ofCritical to Quality indices and share with project team/operations recommendations and solutions to emerging issues.
Improve key quality metrics (Fist Pass Acceptance, Quality Notifications and Complaint data).
Develop department programs / processes on continuous improvement and standardization across the BD Diagnostic Systems.
Supports the coordinated integration of new products into Manufacturing / Operations.
Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.
Develop Design / Device History Files and maintain in a manner consistent with FDA (Food and Drug Administration) requirements
Understanding of Quality Systems and procedures
Other emerging responsibilities as identified and assigned.
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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.
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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
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Job ID: 147893177
Skills:
Design Device History Files, Quality Systems
Skills:
Performance Monitoring, 8D methodologies, SAP systems, qualification processes, Minitab, RCCA, NCR handling, supplier quality management, Supplier Audits, Jmp
Skills:
systems engineering principles, quality standards, Document Management, project program management, process improvement, QMS governance
Skills:
Power Bi, Power Automate, Quality Management Systems, Iso 9001, Document Control, VDA6.3, Auditing practice, IATF 16949, Quality tools and methodologies, Data analytics tools, 5 Core Tools
Skills:
Gas Analytical Equipment, Iso 9001, Gas Chromatography, Quality Management Systems, Corrective and Preventive Actions, Root Cause Analysis
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