Site CAPA Leader/ Quality Culture/ Systems

Job Description Summary

GENERAL FUNCTION

To assist the site CAPA owners, investigators and approvers on each and every CAPA. Provide training and guidance on the CAPA process to the organization. Monitor every CAPA at each phase. Report to Management status and risks on the CAPAs Drive Quality Culture improvement programs Support Quality Systems initiatives Support Change Control. 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.

RESPONSIBILITY

Essential responsibilities include but are not limited to: Owner of the CAPA process Good understanding of the Manufacturing processes and Quality System. Promote/ Leading / mentoring / conducting quality improvement projects thru continuous improvement initiatives. May obtain Green/Black Belt Certification. Assist in the acceptance and validation of process equipment. Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality, cost. Assume a role of leadership in analyzing and resolving issues, which lead to strengthening the CAPAs effectiveness. Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices. Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements. Provide support and guidance on quality/ process improvements. Ensure that all company safety rules and regulations are followed and promote general plant safety. Assist in internal/ external audits as needed. Other duties, as assigned

KNOWLEDGE AND EXPERIENCE EDUCATION

Required:

Bachelor of Science degree

EXPERIENCE

Required:

5 years manufacturing experience with broad background in manufacturing processes 3 years CAPA Process 2 years Quality manufacturing experience Proven history of product / process improvements utilizing Green/ Black Belt/Six Sigma techniques. Ability to generate validation protocols, which comply with the globalization standardization initiative. Experience working in medical device manufacturing industry Experience in metrology and gauge fixture design preferred. Experience working with high performing work teams desired Certificate in Quality Auditing 3 years practical GMP / Medical Device manufacturing experience. •Resume required for consideration• 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. BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families. Competitive pay Access a portion of your pay before pay day with DailyPay Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover. Preventive care covered at 100%. Dental and vision insurance at group rates. Paid parental leave up to 6 weeks Adoption assistance plan 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation Company paid basic life and AD&D insurance Tuition reimbursement Discounted home, auto and pet insurance Paid holidays and vacation (pro-rated the first year based on actual start date) All benefits and policies are subject to eligibility and enrollment requirements. Most coverage begins on your first day or the date you become eligible for benefits. 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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics. #LI-ISC Required Skills Optional Skills . Primary Work Location USA NE - Columbus (West) Additional Locations Work Shift