Source Quality & Compliance Specialist - Audit Ready

Johnson & Johnson MedTech; Guaynabo (PR); On-site; USD 94,000 - 152,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Staff Source Compliance Specialist to establish and maintain a robust regulatory compliance program across sites, including Guaynabo, PR, ensuring adherence to FDA, GMP and JJ policies.

You will lead internal and external audit readiness, manage CAPAs, and act as SPOC for audit support within the Source Quality global team, collaborating with site leadership and regulatory partners to uphold the highest quality standards.

Qualifications

• A bachelor’s degree in engineering, Applied Science or related technical field is required.
• At least 4 years of work experience in a highly regulated Industry is required.
• Practical experience with GMP documentation and writing skills in the FDA regulated environment is required.
• At least 2 years of experience in external audit readiness and management is preferred.
• Source Quality or Procurement experience is preferred.
• Strong Communications Skills in English (Written and Oral)

Responsibilities

• Lead and manage internal/external audit readiness activities to ensure readiness.
• Partner with site leadership to support internal/external audits (Notified Body, Health Authority, FDA, etc.).
• Provide timely information to support audit/inspection processes.
• Ensure external audit results are reported to management and communicate potential non-conformities.
• Provide guidance to prepare responses to internal/external audit/inspection notices.
• Manage corrective/preventive actions and closure of audit findings.
• Escalate quality issues and provide regular updates to management.

Skills

Strong Communications Skills in Eng

Education

Bachelor's degree in engineering or related technical field

Job description

Johnson & Johnson MedTech is seeking a Staff Source Compliance Specialist to establish and maintain a robust regulatory compliance program across sites, including Guaynabo, PR, ensuring adherence to FDA, GMP and JJ policies.

You will lead internal and external audit readiness, manage CAPAs, and act as SPOC for audit support within the Source Quality global team, collaborating with site leadership and regulatory partners to uphold the highest quality standards.