Sr Quality & Compliance Specialist (MedTech)

Location: Fully remote throughout the United States; West Chester, Pennsylvania is also listed as a job location. Up to 25% domestic and international travel may be required.

Salary: $94,000–$151,800 annual base pay

Company

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

What you will do

• Define, implement, and validate quality requirements and systems for orthopedic last-mile operations.
• Act as the primary quality contact for assigned operations and collaborate with Quality, Supply Chain, Delivery, Sales, and Commercial partners.
• Lead audits, inspections, investigations, remediation activities, and inspection-readiness programs.
• Support quality for new and existing distribution processes, go-to-market models, field inventory, loaner sites, and distribution centers.
• Develop, implement, and review standard operating procedures and improve validation, calibration, preventive maintenance, and delivery-service processes.
• Investigate nonconformances, develop corrective action plans, monitor effectiveness, and coach functional teams on ISO and cGMP requirements.

Requirements

• Bachelor’s degree or equivalent university degree.
• 6–7 years of relevant experience in regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems environments.
• Working knowledge of FDA CFR 820, ISO 13485, ISO 9001, and quality system requirements for medical devices, commercial distribution, and field inventory.
• Experience with quality systems, document control, training compliance, quality metrics, audits, nonconformance management, and corrective action processes.
• Strong communication, collaboration, critical-thinking, problem-solving, root-cause analysis, technical-writing, and documentation skills.
• Proficiency with Microsoft Office, data analysis, and quality-system applications.

Nice to have

• Experience with Windchill, ETQ, Summit, ERP, warehouse management, document management, learning management, or related quality-system platforms.
• Experience with audit preparation, inspection readiness, regulatory responses, or health-authority interactions.
• Lean, Six Sigma, 5S, ASQ, ISO 13485, Good Distribution Practices, supplier quality, or other quality-improvement training or certifications.

Culture & Benefits

• Fully remote work throughout the United States may be approved on a case-by-case basis.
• Up to 25% domestic and international travel may be required.
• Benefits include a pension and 401(k) savings plan.
• Paid vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off are available subject to applicable plans and policies.
• Inclusive employment practices and accommodation support are provided.