Job Description Summary

The Staff Quality Engineer is a key member of the New Products Development Team and is responsible for QA-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.

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. 

The Staff Quality Engineer is a key member of the New Products Development Team and is responsible for QA-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. 

Duties include: 

• 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.

Qualifications: 

• Bachelor’s degree in a relevant degree field (engineering)

• Minimum 8 years’ experience with emphasis on R&D development, Quality Engineering and Design Control 

• Experience working with software development and agile processes.

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

• 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 skills with the ability to work in a team environment 

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can