Quality Systems Specialist I – CAPA & Audit Expert

Becton Dickinson; Franklin Lakes (NJ); On-site; USD 136,000 - 217,000; Full time

Benefits offered by this job

Annual Bonus Potential

Medical coverage

BD 401(k) Plan

Life and AD&D insurance

Paid time off

Job summary

Becton, Dickinson and Company (BD) in the USA is seeking an experienced CAPA/audit leader to manage site quality systems and drive CAPA, audits, and QN processes. You’ll coordinate internal and external audits, coach cross-functional teams, and analyze quality metrics to support continuous improvement.

Ideal candidates have a BS in engineering/science and 8+ years in medical device/biologic/pharma settings with strong regulatory knowledge and SME capabilities.

Qualifications

• BS degree in Engineering, Science, or related discipline.
• 8+ years of medical device, biologic, pharmaceutical, or diagnostic industry experience.
• Strong knowledge of US/international regulations and standards (21 CFR 820, ISO 13485, MDD/MDR, MDSAP).

Responsibilities

• Develops site procedures and work instructions; updates unit-level procedures as needed.
• Serves as Site CAPA Leader and as SME for CAPA content and TrackWise.
• Leads CAPA Board meetings and coordinates with WW CAPA Board.
• Acts as Site Audit Manager and ensures internal/external audits are completed.
• Supports inspection activities and records responses and closure activities.
• Acts as SME for audit processes and electronic tools utilization.
• Coaches cross-functional teams in problem solving as SME.
• Tracks trends in CAPA, audits, QNs and reports metrics.

Skills

CAPA

Audits

Quality systems

Problem solving

Analytical skills

Regulatory knowledge

Cross-functional collaboration

Communication

Education

BS degree in Engineering, Science, or related discipline

Tools

TrackWise

QMS software

Job description

Becton, Dickinson and Company (BD) in the USA is seeking an experienced CAPA/audit leader to manage site quality systems and drive CAPA, audits, and QN processes. You’ll coordinate internal and external audits, coach cross-functional teams, and analyze quality metrics to support continuous improvement.

Ideal candidates have a BS in engineering/science and 8+ years in medical device/biologic/pharma settings with strong regulatory knowledge and SME capabilities.