CAPA Leader: Quality Culture & Systems

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

Benefits offered by this job

DailyPay

Healthcare coverage

Paid parental leave

401(k) plan with match

Tuition reimbursement

Discounted insurance options

Job summary

BD in the USA seeks a Quality/ CAPA professional to own the CAPA process, drive continuous improvement, and ensure GMP compliance across medical device manufacturing. You will analyze data, implement corrective actions, and sustain robust quality systems that support product safety and reliability.

You will collaborate with manufacturing, QA, regulatory affairs, and design teams; lead audits and training; mentor colleagues; and help shape a culture of quality, accountability, and patient-first

Qualifications

• Bachelor degree required in science or engineering.
• 5 years manufacturing experience in medical devices.
• 3 years CAPA process experience.
• Proven product/process improvement with Six Sigma.
• Experience with validation protocols.
• Knowledge of GMP and regulatory compliance.

Responsibilities

• Own the CAPA process from initiation to closure.
• Review and improve manufacturing processes for quality and cost.
• Lead quality improvement projects.
• Support audits and regulatory compliance.
• Provide guidance on quality improvements.

Skills

CAPA process

Quality systems

GMP knowledge

Six Sigma

Data analysis

Education

Bachelor of Science

Tools

Metrology

Gauge fixtures

Validation protocols

Job description

BD in the USA seeks a Quality/ CAPA professional to own the CAPA process, drive continuous improvement, and ensure GMP compliance across medical device manufacturing. You will analyze data, implement corrective actions, and sustain robust quality systems that support product safety and reliability.

You will collaborate with manufacturing, QA, regulatory affairs, and design teams; lead audits and training; mentor colleagues; and help shape a culture of quality, accountability, and patient-first