Compliance Specialist IV (MedTech)

Location: New Brunswick, New Jersey, United States; may telecommute. Up to 20% domestic travel required.

Salary: $134,000–$148,000 per year.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions, including surgical and orthopedic products.

What you will do

• Develop, execute, and oversee Quality and Compliance programs for MedTech US field inventory, field sales offices, loaner sites, and distribution centers.
• Support last-mile delivery of surgical loaner sets for joint reconstruction and orthopedic customers across the US.
• Partner with Quality, Distribution, Sales, Commercial, and Supply Chain teams to resolve distribution quality issues.
• Lead and participate in audits, inspections, investigations, remediation, and inspection-readiness activities.
• Develop, implement, validate, and improve quality systems, standard operating procedures, and distribution processes.
• Manage commercial quality, process changes, validation, calibration, preventive maintenance, delivery issue trending, and corrective actions.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Six years of experience in the offered role or a related Compliance Specialist IV occupation.
• Experience with Lean management, Quality Assurance, quality program leadership, audit management, validation, and compliance.
• Experience developing, implementing, and reviewing Standard Operating Procedures.
• Experience with process improvement, including value-based healthcare, Agile methodology, root cause analysis, statistical process control, process mapping, and reengineering.
• Experience with external sales agents or consignment models, health authorities or notified bodies, FDA regulations, and ISO 13485 standards.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and equal opportunity.
• Medical, dental, vision, retirement, pension, and 401(k) benefits.
• Vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.
• Eligibility for the long-term incentive program.
• Accommodation support is available throughout the interview process.