Job Description Summary

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. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Excited to grow your career?

We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!

Our people make all the difference in our success.

The Staff Quality Engineer is a key member of the New Products Development Team and is responsible for Quality Assurance related R&D activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects.

You will be Accountable for the Following:

• Responsible for being the core team Ops Quality representative for design control projects – new product development as well as sustaining efforts.

• Lead Quality efforts for successful Design Transfer of ongoing changes to commercialized products and for new products coming into manufacturing for the first time

• Provide clarification and guidance to teams on overall quality system with emphasis in design controls.

• Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.

• Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.).

• Identifies Product Quality improvements directly linked to better outcomes in the customer experience and compliance position (Nonconformances, early failures, failures at install, etc.) and act as the champion to push projects forward.

• Ownership of data analysis on ISC/Ops Quality owned Quality metrics (NCs, Failures at Installation (FAI), Out of Box Failures (OOB), etc.. to identify improvement opportunities.

• Proactively engage partners to drive consensus and resolve issues in a timely fashion.

• Provide statistical support and expertise in analytical problem solving (e.g. Root Cause, DMAIC, etc.) for manufacturing activities, specifically Process Qualification.

• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams

• Actively coach and mentor other QEs on the team with some leadership responsibilities as assigned.

• Communication to senior leaders on status of ongoing Quality investigations, projects and other Operations Quality activities.

• Ownership of all aspects of Operations Quality for the assigned product (reporting of key metrics, driving quality investigations to closure, resolution of manufacturing impacting issues, etc.).

What Success Looks Like in This Role:

• Demonstrates strong knowledge of quality engineering policies, principles and best practices

• Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision

• Applies comprehensive knowledge of Design Transfer activities with the Operations environment

• Knowledge of product development processes and application of Design Controls

• Represents Operations Quality organization on cross-functional product development Core Team(s)

• Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place

• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)

• Applies knowledge and skills to a wide range of standard and non-standard situations

• Works independently with minimal guidance and determines own work priorities

• Acts as a resource for colleagues with less experience<