CAPA Leader & Quality Culture Champion

Becton Dickinson; Columbus (NE); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive pay

DailyPay

Healthcare benefits and 401(k)

On-site collaboration

Job summary

Becton Dickinson in the United States - Nebraska region (Columbus) is seeking an experienced CAPA/quality professional to own the CAPA process and improve manufacturing quality. You will lead improvement projects, mentor teams, and help validate processes and equipment in a regulated medical device setting.

The role requires 5+ years in manufacturing with CAPA experience and a solid Six Sigma background. Candidates may pursue Green/Black Belt certification and must align with GMP standards and

Qualifications

• Bachelor of Science degree.
• 5 years manufacturing experience with broad background in manufacturing processes.
• 3 years CAPA Process.
• 2 years Quality manufacturing experience.
• Proven history of product / process improvements utilizing Green/ Black Belt/Six Sigma techniques.
• Ability to generate validation protocols, which comply with the globalization standardization initiative.
• Experience working in medical device manufacturing industry.
• Experience in metrology and gauge fixture design preferred.
• Experience working with high performing work teams desired.
• Certificate in Quality Auditing 3 years practical GMP / Medical Device manufacturing experience.

Responsibilities

• Owner of the CAPA process.
• Good understanding of the Manufacturing processes and Quality System.
• Promote/ Leading / mentoring / conducting 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.
• Assume a role of leadership in analyzing and resolving issues, which lead to strengthening the CAPAs effectiveness.
• Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices.
• Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements.
• Provide support and guidance on quality/ process improvements.
• Ensure that all company safety rules and regulations are followed and promote general plant safety.
• Assist in internal/ external audits as needed.
• Other duties, as assigned

Skills

CAPA process

Quality systems

Six Sigma

GMP

Manufacturing

Leadership

Education

Bachelor of Science degree

Tools

Metrology

Gauge fixture design

Job description

Becton Dickinson in the United States - Nebraska region (Columbus) is seeking an experienced CAPA/quality professional to own the CAPA process and improve manufacturing quality. You will lead improvement projects, mentor teams, and help validate processes and equipment in a regulated medical device setting.

The role requires 5+ years in manufacturing with CAPA experience and a solid Six Sigma background. Candidates may pursue Green/Black Belt certification and must align with GMP standards and