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. 

Summary

As directed by the Sr. Quality Manager, the Staff Quality Engineer I is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Responsibilities

• Extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measurable / confirmed results.

• Track record of root cause determination and effective corrective / preventive action implementation. 

• Provides training for product development teams and continuous improvement team on best practices.

• Conducts audits as member of a quality system audit team (e.g. SME, etc.)

• Writes and leads risk management activities including risk management reports and risk analyses.

• May perform other duties as required.

Position-Specific Overview

• Design Controls   

  • Design Input

  • Design Output

  • Design Verification plans, protocols, and reports

  • Design Reviews

  • Design Validation

  • Design History File support

• Change control

  • Assessment of Change Request (ACR) Responses

• Risk Management

• Process Validations

• Identification of CTQ's

• Unit Quality Independent Reviewer During Design Reviews

• Handling of deviations and non-conformances

• Test method validations

• Supplier qualification

• Software validations

• Post Market Surveillance

• Situation Analysis

• CAPA – Root cause investigation and implementation of corrective / preventive actions

• Proper Use of Statistics (Sampling Plans)

• Advise on Regulations

• Liaise with Manufacturing Plants

• Provide functional support to cross-functional teams

• Internal and external audits

Requirements

Education

• Bachelor’s Degree

• Certified Quality Engineer and Certified Quality Auditor (preferred). 

Experience

• A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.   

Knowledge

• Extensive knowledge of applicable regulatory, Corporate and / or Unit requirements.​​

• Training in design of experiments and statistics. 

• Class II / III medical device experience.  

• Knowledge of six sigma methodology preferred.   

• Knowledge of design control principles (preferred). 

• Ability to support internal / external audits.

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. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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