JOB DESCRIPTION SUMMARY

As directed by the Quality Associate Director, the Staff Quality Engineer II 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:

• Mentors teams for application of technical principles, theories, concepts and quality, tools and systems
• Develops technical solutions to complex problems which require the regular use of ingenuity and creativity.
• Develops advanced technological ideas and guides their development into a final product, process or business opportunity.
• Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work.
• Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context
• Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives
• Is a core team member for complex design control / process control projects.
• Act as a CAPA expert
• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.
• Supports and leads quality system audits.
• Provides input to management review process

ABILITY AND KNOWLEDGE IN THE FOLLOWING AREAS, HOWEVER ARE NOT LIMITED TO:

• Design Control, Input/Output, verification plans, protocols, reports, reviews and validation.
• Design History File support
• Change control
• Risk Management
• Process Validations
• Identification of CTQ’s
• Unit Quality Independent Reviewer During Design Reviews
• 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
• Support to cross-functional teams
• Internal and external audits
• Regulatory, Corporate and / or Unit requirements.

REQUIRED QUALIFICATIONS:

• Bachelor’s Degree in Engineering, Science, or Math
• 8 years relevant experience
• Experience with design control principles, design of experiments and statistics.
• Class II / III medical device experience.

PREFERRED QUALIFICATIONS:

• Knowledge of six sigma methodology
• Certified Quality Engineer or 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 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 Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

• Mentors teams for application of technical principles, theories, concepts and quality, tools and systems
• Develops technical solutions to complex problems which require the regular use of ingenuity and creativity.
• Develops advanced technological ideas and guides their development into a final product, process or business opportunity.
• Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work.
• Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context
• Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives
• Is a core team member for complex design control / process control projects.
• Act as a CAPA expert
• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.
• Supports and leads quality system audits.
• Provides input to management review proces