Job Description Summary

This position will work with cross-functional CAPA action item leader and CAPA owners. We are looking to transform our CAPA process to a best in class system, where project management will play a key role in helping to achieve timely and successful completion of CAPA projects across our entire Quality Management System. The ideal candidate will bring to the table a positive attitude, will be a self-starter that also has change management experience and the drive to achieve quick wins in sometimes ambiguous situations.

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. 

This position will be located in San Diego at our Medication Management Solutions headquarters, working with multi-functional CAPA action item leader and CAPA owners. We are looking to transform our CAPA process to a best in class system, where project management will play a key role in helping to achieve timely and successful completion of CAPA projects across our entire Quality Management System. The ideal candidate will provide a positive attitude, will be a self-starter that also has organizational change experience and the drive to achieve quick wins in sometimes ambiguous situations.

As a Staff Quality Engineer - CAPA, you will have responsibility for coordinating the BD Quality CAPA portfolio. Coordination includes partnering with those team members to define, investigate, implement, and resolve product and quality systems issues to ensure they don't recur. This position will be responsible for additional Quality Management System project work as needed.

Responsibilities may include the following and other duties may be assigned.

• Provide continuous and rigorous assessment of CAPA activities and documentation to assure compliance with BD internal policies in general and specific to CAPA process, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations through the review of CAPA records at critical phases.

• Participate in CAPA Board activity and perform CAPA activities in Trackwise. Provide guidance, support, and mentorship to CAPA Owners regarding the CAPA process, CAPA standard methodologies, CAPA record content, and CAPA software tools.

• Collaborates with engineering and support functions to ensure quality standards are in place.

• Devises and implements methods and procedures for inspecting, testing, and evaluating the effectiveness and accuracy of corrective actions ensuring no impact to products, processes or patient safety.

• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with regulatory requirements.

• May support CAPA in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

• Will train, coach, guide & mentor CAPA process stakeholders on both base CAPA process execution and best practices employed to ensure robust quality record generation for CAPA and related records.

Must Have (Minimum Requirements)

• To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree in Engineering or Science is required

• Minimum of 4 years of CAPA/Quality experience OR advanced degree with a minimum of 2 years of CAPA/Quality experience

Nice to Have (Preferred Qualifications)

• Experience conducting effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.

• Support CAPA process and several individual records for a specific set of CAPAs that will have high visibility and require increased oversight.

• Experience in medical device, pharmaceutical and/or a comparable regulated environment.

• Experience working with non-conformances, corrective and preventive actions.

• Strong analytical, process improv