Quality Systems Leader - CAPA, Audits & Compliance

BD; Franklin Lakes (NJ); On-site; USD 135,500 - 216,800; Full time

Job summary

BD in the United States is seeking a Quality Assurance leader to drive CAPA, audits, and quality-system activities at the Franklin Lakes site. You will collaborate with Quality Engineering, R&D, Operations, and other functions to implement policies and improve performance.

This role requires a BS in Engineering or related field and at least eight years in medical device or related industries. You will coordinate with internal and external audits (FDA/ISO), manage CAPA board activities, and

Qualifications

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

Responsibilities

• Develops and updates site/unit procedures and work instructions.
• Acts as Site CAPA Leader; SME on CAPA content and Trackwise usage.
• Leads site CAPA Board meetings and coordinates with WW CAPA Board.
• Handles site audits and ensures compliance with FDA, ISO, and other audits.
• Coordinates Quality Notifications (NCs and Planned Deviations) content and activities.
• Leads or supports root-cause analysis and problem-solving with cross-functional teams.
• Tracks trends in CAPA, Audits, QNs and reports metrics.
• Maintains site and WW Quality Systems and supports continuous improvement.
• Collaborates with Quality Eng, R&D, Operations, Medical, Marketing on policy development.

Job description

BD in the United States is seeking a Quality Assurance leader to drive CAPA, audits, and quality-system activities at the Franklin Lakes site. You will collaborate with Quality Engineering, R&D, Operations, and other functions to implement policies and improve performance.

This role requires a BS in Engineering or related field and at least eight years in medical device or related industries. You will coordinate with internal and external audits (FDA/ISO), manage CAPA board activities, and