CAPA Leader: Quality Systems & Continuous Improvement

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

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.