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

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.