Sr. Quality Engineer

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.

• →Monitor, analyze, and trend quality indicators for purchased materials, as well as manufactured and distributed components and products, to drive product quality and performance improvements.
• →Evaluate Critical to Quality (CTQ) parameters and risk assessment variables to support informed decision-making, predictable product design, and efficient product flow.
• →Serve as a key Quality Management (QM) Engineering resource, supporting both Media QM Engineering initiatives and day-to-day quality engineering activities for assigned products and operational areas.
• →Partner closely with the Plant Senior Quality Manager to ensure the consistent implementation and application of Quality Systems across new and existing product lines, as well as Enterprise business systems.
• →Support compliance with ISO, FDA, and internal quality requirements through: Internal and external audit participation, Cross-functional team collaboration, Project support and execution, Product launches and transfers, Process improvement initiatives, CAPA coordination and resolution, Product quality notifications, Change notifications, Customer complaint investigations and follow-up
• →Utilize root cause analysis methodologies and quality tools to identify issues, drive investigations, and implement effective corrective and preventive actions.
• →Develop, execute, and monitor corrective action plans to address quality concerns and drive sustainable improvements.
• →Leverage Enterprise tools and systems to ensure regulatory compliance, improve visibility, and streamline quality processes.
• →Collaborate across functions to promote continuous improvement, strengthen quality system effectiveness, and support operational excellence.

• Bachelor’s degree in sciences or other relevant technical fiield
• 3 years’ experience in Quality Engineering or other related field.
• Experience in a medical device, pharmaceutical manufacturing facility, or other relevant manufacturing field.

• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Preferred and additional skills and qualifications
• Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization ISO 13485 and 14971.
• Minitab experience is a plus.
• Familiarity with Six sigma, Lean Tools, root cause analysis, and project management techniques
• Ability to represent functional and operations organization with transparency and lead conflict resolution in wide variety of settings.
• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems.
   

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.