Quality Systems Specialist I — CAPA & Audit Expert

Regulatory Jobs; Franklin (NJ); On-site; USD 136,000 - 217,000; Full time

Benefits offered by this job

Annual Bonus

Discretionary LTI Bonus

Phone use reimbursement

Medical coverage

Health Savings Accounts

Job summary

BD, a leader in medical technology, seeks a senior QA/Regulatory Compliance professional to manage CAPA, audits, and quality systems at the USA NJ facility. The role emphasizes cross-functional collaboration, process improvement, and ensuring regulatory adherence across US and international standards.

The position offers a comprehensive rewards package and a focus on improving quality for BD’s global products and patients.

Qualifications

• BS degree in Engineering, Science, or related discipline.
• Strong knowledge of US and international medical device regulations and standards.

Responsibilities

• Develops site procedures and work instructions and updates unit level procedures.
• Acts as Site CAPA Leader and SME for CAPA content and TrackWise use.
• Serves as site Audit Manager to ensure internal and external audits are met and coordinated.
• Supports pre- and post-inspection activities, hosting logistics, coaching SMEs, and tracking responses and actions.
• Acts as SME for QN content, process, and electronic tools utilization.
• Leads or supports problem-solving and root cause analysis; coaches cross-functional teams.
• Tracks trends in CAPA, audits, QNs; analyzes and reports metrics.
• Maintains Site and WW Quality Systems and supports continuous improvement.

Skills

CAPA leadership

Audit management

Regulatory knowledge

Problem solving

Education

BS degree in Engineering/Science/related

Tools

TrackWise

Job description

BD, a leader in medical technology, seeks a senior QA/Regulatory Compliance professional to manage CAPA, audits, and quality systems at the USA NJ facility. The role emphasizes cross-functional collaboration, process improvement, and ensuring regulatory adherence across US and international standards.

The position offers a comprehensive rewards package and a focus on improving quality for BD’s global products and patients.