Job Description Summary

As directed by the Quality Associate Director, 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.

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: 

• 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.

Strategic Orientation:

• Guides the successful completion of major programs and may function in a project leadership role. 

• Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations.

• Decisions, recommendations and results further the achievement of goals critical to organizational objectives

• Implements and communicates the strategic and technical direction for the product/project team

• Identifies any issues that may delay product or project and recommends appropriate action to be taken.

Support of the following areas, however are not limited to:

• Design Control   

• 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

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

• Training in design of experiments and statistics. 

• Ability to support internal / external audits.

Required Qualifications:

• Bachelor’s Degree and 8 years relevant experience  

• Class II / III medical device experience.   

Preferred Qualifications:

• Knowledge of six sigma methodology
• Knowledge of design control principles
• Certified Quality Engineer and Certified Quality Auditor

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 smo