Job Description Summary

Responsible for all aspects (product and process) related to the quality of the Instrument Plant for the designated product line(s). This includes manufacturability of products at the Instrument Plant, supplier manufacturing, customer requirements and complaints. The Senior Quality Engineer will be responsible for developing and maintaining the Design History File, product and supplier quality. Develops, modifies, applies and maintains quality standards and protocols.

Job Description

We are the makers of possible

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.

• 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.
• Generate process/product quality information in the form of Critical 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.

• Support new product development teams and being able to represent quality in cross-functional team settings.
• Perform trend analysis, FMEA (Failure Mode and Effect Analysis) and six sigma tools.

• Bachelor's degree (Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.)

• Experience and understanding of electro-mechanical instrumented systems. Professional certifications such as Certified Quality Auditor/Certified Quality Engineer, Six Sigma preferred.
• Ability and skill to effectively manage multiple tasks and drive execution of change management plans
• Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC
• Six sigma, additionally root cause analysis and project management techniques are routinely employed
• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
• Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity
• Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution
• Sound workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003
• Professional certification preferred. Six Sigma, ASQ, AAMI
• Experienced in Microsoft Office suite skills. Basic mini tab and/or related analytical software programs
• Preferred: Certification such as ASQ-CQA/CQE, AAMI, Six Sigma or a Company certification such as Green Belt, Black Belt, IGQA auditor.
• Knowledgeable in specific automated systems as noted and engaged in new product introductions as a possible Core Team member representing the Quality function.