Site CAPA Leader/ Quality Culture/ Systems

BD; Columbus (NE); On-site; USD 81,000 - 133,000; Full time

Benefits offered by this job

Competitive pay

DailyPay access

Health insurance

Dental and vision insurance

Parental leave

401(k) plan

Job summary

BD is a global medical technology leader delivering transformative solutions in health care. This role focuses on CAPA ownership, driving quality improvements, and ensuring regulatory compliance across manufacturing processes.

The ideal candidate has solid GMP, Six Sigma, and medical device manufacturing experience and will mentor teams to achieve peak performance. Expect on-site collaboration with a focus on continuous improvement, process validation, and adherence to global standards.

Qualifications

• Bachelor of Science degree required.
• 5 years manufacturing experience with broad manufacturing processes.
• 3 years CAPA process experience.
• 2 years quality manufacturing experience.
• Proven history of product/process improvements via Green/Black Belt/Six Sigma techniques.
• Ability to generate validation protocols complying with globalization standardization.
• Experience in medical device manufacturing industry.
• 3 years practical GMP/Medical Device manufacturing experience.
• Resume required for consideration.

Responsibilities

• Own the CAPA process.
• Understand manufacturing processes and Quality System.
• Lead/mentor quality improvement projects through continuous improvement initiatives.
• Assist in acceptance/validation of process equipment.
• Review and develop changes to processes to improve performance and quality, cost.
• Lead in analyzing and resolving issues to strengthen CAPA effectiveness.
• Stay informed on regulatory requirements for medical devices.
• Lead regulatory compliance and train manufacturing unit on requirements.
• Provide support on quality/process improvements.
• Ensure safety rules and regulations are followed and promote plant safety.
• Assist in internal/external audits as needed.
• Other duties as assigned.

Education

Bachelor of Science degree

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

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.

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.

Required Skills

Optional Skills

Primary Work Location

USA CA - San Diego Bldg A&B

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$80,600.00 - $133,000.00 USD Annual