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 improvement, critical thinking, and decision-making skills.

• Ability to educate people in the CAPA program.

• CAPA documentation systems experience (e.g. Trackwise).

• Influence management skills: ability to work constructively across all functions of the organization as well as external customers.

• Project management skills.

• Experience reviewing technical documentation.

• Strong written and verbal communication skills.

• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and quality requirements.

• Experience with internal and external audits.

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.

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 learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$121,100.00 - $199,800.00 USD Annual

Salary : $121,100 - $199,800