Quality Engineer II

Job Description

Summary:

Quality Engineer II will assist the Manufacturing Department in the establishment and implementation of programs designed to assure control of processes and products toward established quality standards. Use problem solving techniques to improve quality within the business. The incumbent will be capable of self-direction and project management to ensure successful outcomes. Successful performance requires close work with quality management, operations, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.

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 Med Tech 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.

• Provide guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.

• Work with Manufacturing operations to implement plant driven changes and provide overall support of process improvements by working with engineering teams to implement process improvements to improve Quality, conducting quality improvement projects through various CI initiatives.

• Develop or update in-process inspection requirements to ensure the greatest value in process control for the customer and the plant during the manufacturing process while meeting regulatory requirements

• Provide assistance in such areas as process/equipment validation, process and product acceptance, audit correction actions, Change Control issuance for process changes.

• Manages completion of assigned complaint investigation files and works with the manufacturing site or suppliers where necessary, to complete the investigation within a timely fashion.

• Support CAPAs as owner or as part of the support team

• Monitor quality data from complaints process, Manufacturing reports, Service reports and customer input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Service, Engineering, Regulatory and Biostatics.

• Work to implement document changes in support of ongoing efforts to simplify internal quality procedures in alignment with business unit and corporate requirements.

• Leading investigations for quality issues resulting in yield issues by using applicable problem solving and root cause techniques.

• Complete training to support Manufacturing Quality for day-to-day operations including assuring product release, manufacturing quality training and Material Review Board (MRB) activities.

• Lead or participate in Risk Management activities appropriate to the initiative or situation.

• Lead situation analysis and support activities relating to Field Corrective Actions, when needed.

• Work collaboratively and cross functionally to improve product performance. Utilize trouble shooting and problem solving skills to identify and eliminate issues that negatively impact product performance

• Bachelor’s degree in Engineering or Science is required.

• A minimum of 3 years of experience Quality manufacturing experience

• A minimum of 3 years of experience working in an FDA or ISO regulated environment/GMP/Medical device manufacturing.

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…