Senior Quality Engineer

Responsibilities

• Drive Quality Excellence: Apply advanced technical principles, quality sciences, and proven methodologies to ensure our medical devices exceed industry standards and regulatory expectations
• Solve Complex Challenges: Leverage your proven problem-solving skills to tackle quality issues head-on, creating measurable improvements to BD's processes and procedures that enhance efficiency and effectiveness
• Champion Regulatory Compliance: Ensure every design control and production/process control project meets all applicable local and international regulatory requirements, plus Corporate and Unit standards
• Collaborate Cross-Functionally: Serve as the Quality representative on dynamic new product development and sustaining engineering teams, bringing your expertise to multidisciplinary projects
• Exercise Approval Authority: Review and provide Quality Engineering approval for new and modified design/process specifications, including product performance specs, test methods, and critical documentation
• Develop Auditing Skills: Participate in supplier and internal quality system audits as an Auditor-in-training, evaluating the effectiveness of our Quality System and good manufacturing practices
• Lead Project Quality: Ensure quality conduct across projects-from design through data interpretation and report generation-for both your work and that of junior team members
• Shape Our Future: Contribute to specific programs and projects that advance our quality capabilities, and prepare/revise policies and procedures that guide our organization
• Own the Journey: Manage projects and tasks from product inception through launch and ongoing maintenance, ensuring products consistently meet quality standards at every stage
• Required Qualifications:
• Bachelor's degree in Engineering and 5 years relevant experience OR
• Master's degree in Engineering and 3 years relevant experience.
• Knowledge and Skills:
• Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Can independently determine and develop approach to solutions.
• Able to provide guidance and work direction to lower level project developers.
• Can design and perform development working independently within defined parameters with minimal supervision required.
• Experience with BD software systems utilized in the Quality Systems is desirable.
• Must have knowledge/specialization in one or more of the following areas:
• Acceptance sampling theory and application
• Statistical process control methods and application
• Measurement system/test method knowledge and analysis
• Quality planning
• Failure analysis investigation
• Design of Experiments
• Process mapping and value stream analysis
• Hypothesis testing
• Descriptive statistics
• Process capability analysis
• Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
• Risk Management
• Supplier quality management
• Auditing
• Design/development tools
• Process validation
• Software validation
• At BD, we are committed to supporting our associates' well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:
• Annual Bonus
• Potential Discretionary LTI Bonus
• Health and Well-being Benefi

Benefits

Additional Information

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 Reporting directly to the Associate Director of Quality, you'll be at the heart of our product development journey, applying your Quality Engineering expertise to both cutting-edge new products and essential product maintenance initiatives. This is your opportunity to make a real impact on patient safety and product excellence throughout the entire product lifecycle.

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