CAPA Lead for MedTech Manufacturing Quality

Regulatory Toolkit; Columbus (NE); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Competitive pay

Healthcare benefits

Bonuses and wellness programs

Job summary

BD (Becton, Dickinson, and Company) is seeking a CAPA/Quality Manufacturing professional to lead CAPA, improve manufacturing processes, and ensure regulatory compliance in a fast-paced medical device environment. The role emphasizes Six Sigma and Green Belt practices, with on-site collaboration and potential GMP-related responsibilities.

Required: BS degree and 5 years manufacturing experience; experience with CAPA, metrology, and validation activities.

Qualifications

• Bachelor of Science degree required.
• Five years manufacturing experience with broad background in manufacturing processes.
• Three years CAPA Process experience.
• Two years Quality manufacturing experience with Green Belt/Six Sigma background.
• Experience in metrology and gauge fixture design preferred.
• GMP/Medical Device manufacturing experience required.
• Quality Auditing certification helpful.

Responsibilities

• Own the CAPA process and lead continuous improvement initiatives.
• Understand manufacturing processes and the Quality System.
• Lead quality improvement projects via Six Sigma methods.
• Assist in acceptance and validation of process equipment.
• Ensure regulatory compliance and training on requirements.
• Support internal and external audits as needed.
• Promote plant safety and compliance.

Skills

CAPA process

Quality manufacturing

Green Belt

Six Sigma

Validation protocols

Metrology

Gauge design

GMP

Team leadership

Education

Bachelor of Science degree

Job description

BD (Becton, Dickinson, and Company) is seeking a CAPA/Quality Manufacturing professional to lead CAPA, improve manufacturing processes, and ensure regulatory compliance in a fast-paced medical device environment. The role emphasizes Six Sigma and Green Belt practices, with on-site collaboration and potential GMP-related responsibilities.

Required: BS degree and 5 years manufacturing experience; experience with CAPA, metrology, and validation activities.