CAPA & Quality Systems Leader — Drive Improvement

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

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