Site CAPA Leader/ Quality Culture/ Systems - Becton Dickinson

BD; Columbus (NE); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

DailyPay

Healthcare coverage

401(k) plan

Tuition reimbursement

Paid holidays

Job summary

BD in Columbus, NE is seeking a Quality/ CAPA professional with 3 years CAPA and 2 years quality manufacturing experience in medical device manufacturing. You will own the CAPA process, drive improvements, validate equipment, and ensure regulatory compliance.

Team leadership and Six Sigma methods are highly valued. The role emphasizes on-site collaboration, adherence to safety and quality standards, and participation in audits and continuous improvement initiatives within a fast-paced healthcare

Qualifications

• Bachelor of Science degree required.
• 3 years CAPA process experience required.
• 2 years quality manufacturing experience required.
• Proven history of product/process improvements using Green/Black Belt/Six Sigma.
• Experience in validating protocols per globalization standardization initiative.
• Experience in medical device manufacturing is required.
• Experience with metrology and gauge fixtures is preferred.
• Experience with high-performing work teams is desired.

Responsibilities

• Own the CAPA process and drive closures.
• Understand manufacturing processes and quality system requirements.
• Lead quality improvement projects through continuous improvement initiatives.
• Assist in acceptance and validation of process equipment.
• Review and develop process changes to improve performance, quality, and cost.
• Lead analysis to strengthen CAPA effectiveness and compliance.
• Stay informed on federal regulations and corporate policies for medical devices.
• Lead and ensure regulatory training for manufacturing.
• Provide guidance on quality and process improvements.
• Support internal and external audits as needed.

Skills

CAPA ownership

Quality manufacturing

Green/Black Belt

Six Sigma

Validation protocols

GxP / GMP

Team leadership

Metrology

Education

Bachelor of Science

Quality Auditing certification

Tools

Gage fixture design

Measurement systems

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.
Responsibility
Job Description

• 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

• 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.
#CLOLI
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 visithttps://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.
Required Skills
Optional Skills
Primary Work Location
USA NE - Columbus (West)
Additional Locations
Work ShiftPandoLogic. Keywords: Medical Scientist, Location: Columbus, NE - 68601