Site CAPA Leader/ Quality Culture/ Systems

Regulatory Jobs; Columbus (NE); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Competitive pay

DailyPay access

Healthcare coverage

Job summary

BD is seeking a qualified professional to own the CAPA process and lead quality improvements in a manufacturing setting. This role focuses on CAPA execution, GMP compliance, and continuous improvement within medical device production.

Ideal candidates will have 5+ years in manufacturing with Six Sigma experience and a Bachelor of Science degree. On-site presence is required with strong collaboration across teams and audits.

Qualifications

• Bachelor's degree in science.
• Minimum 5 years manufacturing experience with broad process knowledge.
• 3 years CAPA experience and 2 years in quality manufacturing.
• Proven Green/Black Belt/Six Sigma project history.
• Experience in medical device manufacturing and GMP.
• Experience in validating protocols aligned to globalization standards.

Responsibilities

• Own the CAPA process and drive improvements.
• Promote quality system compliance and manufacturing process efficiency.
• Lead quality improvement projects through CI initiatives.
• Support audits and regulatory compliance activities.
• Provide guidance on quality/process enhancements and training.
• Uphold safety rules and drive continuous improvement culture.

Skills

CAPA process

Quality improvements

Leadership

Six Sigma

GMP experience

Validation protocols

Metrology

Gauge fixture design

Education

Bachelor of Science degree

Tools

Metrology equipment

Gauge fixture design

Job description

We are the people who give possibilities purpose

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.

Job Description

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

• 3years 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
• 3years 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?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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.

Primary Work Location

USA NE - Columbus (West)