Staff Source Compliance Specialist (MedTech)

Location: Hybrid role based in Guaynabo, Puerto Rico; Cornelia, Georgia; Raritan, New Jersey; or San Angelo, Texas, United States.

Salary: $94,000–$151,800 per year.

Company

Johnson & Johnson MedTech develops innovative, less invasive, and personalized healthcare treatments at the intersection of biology and technology.

What you will do

• Establish and maintain a compliance program covering regulatory requirements, company policies, and purchasing-control procedures.
• Lead internal and external audit readiness, including logistics, subject-matter-expert preparation, audit support, and communications.
• Manage responses to audit observations, including investigations, root-cause analysis, CAPA planning, effectiveness monitoring, and closure.
• Support deployment of J&J Quality System standards and implementation of new regulations and industry standards.
• Coordinate with site leadership and Quality Systems, Regulatory Compliance, Quality Operations, Training, Manufacturing, and regional compliance teams.
• Provide compliance education, regulatory updates, issue escalation, and quality-trend reporting to management.

Requirements

• Bachelor’s degree in engineering, applied science, or a related technical and quality field.
• At least 4 years of experience in a highly regulated industry.
• Practical experience with GMP documentation and technical writing in an FDA-regulated environment.
• Strong written and oral English communication skills.
• Ability to work in a hybrid arrangement from one of the listed United States or Puerto Rico locations.

Nice to have

• At least 2 years of experience in external audit readiness and management.
• Source Quality or procurement experience.
• Experience with ISO 9001, quality control, compliance management, issue escalation, and standard operating procedures.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and equal opportunity.
• Medical, dental, vision, life insurance, disability, business accident, and group legal insurance.
• Pension and 401(k) savings plans.
• Paid vacation, sick time, holidays, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off.