Quality Systems Lead: CAPA & Audits

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

Benefits offered by this job

Annual Bonus

Potential Discretionary LTI Bonus

Phone reimbursement

Job summary

BD in USA NJ - Franklin Lakes seeks a Senior Quality & Regulatory Leader to oversee CAPA, audits, and quality systems across the site. The role requires leading cross-functional teams and ensuring compliance with 21 CFR 820, ISO 13485, and related standards.

Ideal candidates hold a BS in engineering/science with 8+ years of industry experience and possess strong analytical, communication, and problem-solving skills.

Qualifications

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

Responsibilities

• Develops site/unit procedures and updates unit policies.
• Acts as Site CAPA Leader and SME for CAPA content and TrackWise use.
• Serves as Site Audit Manager coordinating internal and external audits (FDA, ISO, etc.).
• Coaches and leads CAPA/QA problem-solving across cross-functional teams.
• Tracks quality data trends and reports metrics (CAPA, Audits, QNs).
• Supports Management Review content and continuous improvement of Quality Systems.

Skills

CAPA leadership

Audit management

Quality systems

Regulatory knowledge

Root cause analysis

Data analytics

Cross-functional teamwork

Communication

Education

BS degree in Engineering/Science

Tools

TrackWise

Quality tools

Job description

BD in USA NJ - Franklin Lakes seeks a Senior Quality & Regulatory Leader to oversee CAPA, audits, and quality systems across the site. The role requires leading cross-functional teams and ensuring compliance with 21 CFR 820, ISO 13485, and related standards.

Ideal candidates hold a BS in engineering/science with 8+ years of industry experience and possess strong analytical, communication, and problem-solving skills.