QA & Compliance Leader for Medical Devices

Sterigenics; Salem (NJ); On-site; USD 92,000 - 149,000; Full time

Job summary

Sotera Health is seeking a Quality Assurance Manager to lead QA and validations at our Salem, NJ facility, ensuring product safety, regulatory compliance, and data integrity across all quality functions. You will coordinate FDA, ISO, and internal audits, investigate non-conformances, implement corrective actions, and drive continuous improvement.

The role supervises QA staff, aligns with Operations and Corporate Quality, and supports training and documentation to sustain a best-in-class quality

Qualifications

• Minimum BA or BS in a related field.
• 3–5 years of quality assurance experience in the medical services/products area or equivalent.
• Excellent written and verbal communication skills; demonstrated leadership ability.

Responsibilities

• Maintain compliance with FDA, OSHA, EPA, USDA, NRC requirements.
• Coordinate audits and ensure proper documentation; report findings.
• Lead QA/Validations activities and drive process improvements; retraining where needed.
• Manage personnel records and training related to quality systems.

Skills

Quality assurance

Leadership

Communication skills

Computer skills

Education

BA/BS in related field

Job description

Sotera Health is seeking a Quality Assurance Manager to lead QA and validations at our Salem, NJ facility, ensuring product safety, regulatory compliance, and data integrity across all quality functions. You will coordinate FDA, ISO, and internal audits, investigate non-conformances, implement corrective actions, and drive continuous improvement.

The role supervises QA staff, aligns with Operations and Corporate Quality, and supports training and documentation to sustain a best-in-class quality