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 quality representative for design control projects – new product development as well as sustaining efforts.

• Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.

• 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.

• Works together with Quality Engineers to ensure effective verification of design specifications and requirements.

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

• Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation.

• Active participant in the development of product requirement, product system hazard analysis and design reviews.

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

• Provide statistical support and expertise and analytical problem solving for product development and manufacturing

• Ensure product technical files and Design History Files are complete and auditable.

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

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 software quality concepts within the software development lifecycle

• Knowledge of product development processes

• Represents 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

• Usually determines own work priorities

• Acts as a resource for colleagues with less experience

Basic Qualifications:

• Bachelor’s degree in Engineering (or relevant STEM field) and minimum 8 years’ experience with emphasis on R&D development, Quality Engineering and Design Control

• Experience with software and hardware development within a regulated environment is preferred.

• Thorough understanding of the risk management and quality by design is preferred

• Attentiveness to details with strong organizational skills

• Ability to work proactively and independently

• Ability to multi-task and efficient in time management

• Excellent verbal communication and interpersonal