Supplier Quality Engineer
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
Job Responsibilities
Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
Support internal and supplier root cause investigations and CAPA. Drive corrective actions for supplier process by driving suppliers to true root cause analysis and corrective and Preventive actions
Manage and escalate supplier issues when intervention or a change at a supplier is necessary. Plan, execute, report and follow-up on supplier quality system audits
Partner with Procurement, R&D, Engineering/TechnicalOperations, Quality, Operations, and Suppliers in the timely investigation, resolution/preventionof supplier-related issues to minimize/prevent business disruptions.
Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.
Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.
Utilize analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Worldwide Supplier Quality Management Team.
Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Lead discussions to drive resolution.
Collaborate with operations and franchise operations development on process/product improvement projects.
Prepare Supplier Quality Agreements and drives discussion with supplier while consulting Supplier Quality Manager.
Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts
Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.
Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements
Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).
Responsible for communicating business related issues or opportunities to next management level
Other duties as assigned
Required Qualifications
Bachelor’s degree in Engineering or a related field
5 years Supplier Quality and/or Supplier Development
Understanding of 21 CFR 820, ISO 13485, and ISO 14971 requirements
Prior Supplier Quality experience in a manufacturing plant or technical background
Working experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.)
Demonstrated knowledge of manufacturing principles and practices, and procedures
Direct experience in plant and/or supplier GMP auditing
Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA/SCAR systems and investigations, productionand process controls
Experience with documentation and technical writing skills, in a regulated compliance environment
Demonstrated ability to identify compliance risks and assess business impact
Ability to manage complexity and lead critical discussions
Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches
Bilingual Spanish English
Prior experience with FDA inspection
Preferred
Advanced Degree
Certified Lead Auditor is a plus (ISO 13485)
New product introduction experience
Broad knowledge of QS Regulations and Supplier Management principles
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
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