Staff Quality Engineer - Instruments

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.



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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

Responsibilities:

• Serve as a highly visible quality professional responsible for interpreting and applying Quality System requirements and developing/maintaining/implementing Standard Operating Procedures (SOPs) and organizational policies within the instrument manufacturing plant

• Make key decisions and recommendations that target critical organizational objectives

• Support diagnostic instruments throughout the medical device life cycle, including manufacture, distribution, and post market surveillance

• Ensure the successful completion of major quality system and business initiatives, including serving as project manager and reporting status to leadership

• Provide expert guidance across core Quality System elements, including process control and supplier qualification, while identifying and driving continuous improvement opportunities (both internal and external)

• Expert in the use of statistical tools and data analysis techniques to identify trends and root causes, drive corrective actions, and resolve moderately complex quality issues effectively

• Support internal and external audit activities, ensuring readiness and compliance

• Apply advanced quality engineering principles, technical concepts, and quality science methodologies to deliver measurable and validated results

• Provide training and mentorship to other members of the Quality team as well as guidance on Quality Principles, policies, and best practices cross-functionally

• Identify issues that may delay products or projects and recommend appropriate actions

• Ensure all documentation processes are compliant with applicable regulatory and quality standards

Required Qualifications:

• Bachelor's degree and 10 years experience in a regulated environment.
• Master's degree and 5 years experience in a regulated environment.
• 5 years of experience in Quality Engineering
• Certification in at least one of the following: ASQ-CQA/CQE, AAMI, AOAC, and/or Six Sigma (Green Belt, Black Belt, etc. is preferred.
• Experience in electrical or mechanical engineering preferred

Knowledge and Skills:

• Significant track record of root cause determination and effective corrective / preventive action (CAPA) implementation.

• Ability and skill to effectively manage multiple tasks and lead the successful and timely execution of projects.

• Ability and skill to lead or manage (by influence) the Quality function for engineering projects, reliability concepts for complex systems, validation planning / execution, and continuous improvement projects using statistical sampling, six sigma root cause analysis tools and project management techniques.

• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations.

• Skilled at using systematic analysis tools that include Six Sigma, root cause, failure analysis and risk assessment to gather critical information and diagnosis.

• Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution.

• Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standards (ISO) 13485:2016.

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. …