Site CAPA Leader​/Quality Culture​/Systems

Job Description Summary

• 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.

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.

• Owner of the CAPA process
• Good understanding of the Manufacturing processes and Quality System.
• Promote, leading, mentoring, and conducting quality improvement projects through 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.

Required:

Bachelor of Science degree.

• 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.

• Competitive pay
  Access a portion of your pay before payday with Daily Pay.
• 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.

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://

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.