CAPA & Quality Culture Leader: Drive Continuous Improvement

BD; Columbus (OH); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Competitive pay

DailyPay access

Healthcare coverage

Paid parental leave

Adoption assistance

401(k) with match

Life and AD&D insurance

Tuition reimbursement

Discounted insurance

Paid holidays and vacation

Job summary

BD is seeking a quality leadership professional to own the CAPA process at its Columbus manufacturing site. You will drive continuous improvement, ensure regulatory compliance, and mentor teams across manufacturing and quality systems.

Required: BS degree, 5 years of manufacturing experience with CAPA and quality background; Green/Black Belt Six Sigma certification is a plus. On-site role with strong emphasis on safety and audits.

Qualifications

• Bachelor of Science degree required.
• 5 years manufacturing experience with broad background in manufacturing processes.
• 3 years CAPA Process experience.
• 2 years Quality manufacturing experience.
• Proven history of product/process improvements using Green/Black Belt/Six Sigma.
• Experience with validation protocols per globalization standardization initiative.
• Experience in medical device manufacturing.
• 3 years practical GMP/Medical Device manufacturing experience.
• May obtain Green/Black Belt Certification.

Responsibilities

• Owner of the CAPA process.
• Good understanding of the Manufacturing processes and Quality System.
• Lead 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.
• Lead and resolve issues to strengthen CAPA effectiveness.
• Stay informed as to latest federal regulations and corporate policies regarding medical devices.
• Lead regulatory compliance and training for the manufacturing unit.
• Provide support and guidance on quality/process improvements.
• Ensure safety rules and general plant safety.
• Assist in internal/external audits as needed.
• Other duties, as assigned

Skills

CAPA

Six Sigma

Leadership

Quality improvement

Education

Bachelor of Science degree

Tools

Metrology tools

Job description

BD is seeking a quality leadership professional to own the CAPA process at its Columbus manufacturing site. You will drive continuous improvement, ensure regulatory compliance, and mentor teams across manufacturing and quality systems.

Required: BS degree, 5 years of manufacturing experience with CAPA and quality background; Green/Black Belt Six Sigma certification is a plus. On-site role with strong emphasis on safety and audits.