Job Description Summary

As directed by the Quality Manager, the Sr. Quality Engineer 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. 

Duties and Responsibilities:

• Consistent application of technical principles, theories, concepts and quality sciences / tools

• Makes measurable improvements to BD processes and procedures

• Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements

• Is a team member representing Quality on new product development and sustaining engineering projects

• Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.

• Contributes to the completion of specific programs and projects

• Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers

• Independently determines and develops approach to solution

• May provide guidance and work direction to other team members

• Designs and performs development working independently within defined parameters with minimal supervision required

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

Design Control:

• Design Input

• Design Output

• Design Verification plans, protocols, and reports

• Design Validation

• Design Reviews

• 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

Qualifications:

• Bachelor’s Degree in Mechanical, Electrical, Biomedical or similar or equivalent experience in medical device industry.

• 3-5 years relevant experience or a combination of equivalent education with a medical device company delivering electromechanical software driven instruments or devices.

• Experience in working in quality systems compliant with 21CFR, ISO 13485/14971 and IEC 62304 preferred.

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 lear