Job Description Summary

The Sr. 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. 

Responsibilities:

• 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.

• Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with BD QMS, FDA and equivalent medical device regulations, internationally harmonized consensus standards, 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 is expected of you for success in your role:

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

• Understanding of regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971 to support work with little or no supervision

• Applies comprehensive knowledge throughout product development lifecycle

• Knowledge of hardware, software and firmware 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 and practices (Sampling Plans, Root Cause Analysis, Statistics, etc.)

• Applies knowledge and skills to a wide range of situations

• Works independently with minimal guidance

• Usually determines own work priorities

• Acts as a resource for colleagues with less experience

Qualifications:

• Bachelor’s degree in engineering or life sciences

• Minimum 10 years experience with emphasis on design & development, Quality Engineering and medical device design controls

• Experience with software and hardware development within a medical device 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 skills with the ability to work in a team environment

• Proficiency in Excel, Word, and other desktop/general business systems