QA Manager: Regulatory Compliance & Quality Improvement

Sterigenics U.S., LLC in; Salem (NJ); On-site; USD 92,000 - 149,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Disability insurance

Life Insurance

401(k) with company match

Paid holidays, vacation and sick time

Education assistance

Parental leave

Employee Assistance Program

Job summary

Sotera Health, a global leader in sterilization and lab testing, seeks a Quality Assurance Manager for its Salem facility. Reporting to the General Manager, the role oversees all quality functions, ensures compliance with regulatory requirements, and drives corrective actions and process improvements to safeguard patient safety.

Responsibilities include managing audits (FDA/ISO), maintaining quality records, supporting QA/Validations, change control, and coordination with operations for

Qualifications

• Excellent written and verbal communication skills.
• Above average computer skills.

Responsibilities

• Maintain regulatory compliance with FDA, OSHA, EPA, USDA and NRC as applicable.
• Coordinate actions to determine and report causes of non-conformances and implement corrective actions.
• Oversee change control processes and retraining.
• Coordinate FDA, ISO, customer, internal & other regulatory audits and maintain records.
• Maintain facility quality records and dosimetry records; support QA/Validations tasks as required.

Skills

Communication skills

Computer skills

Education

BA or BS in related field

Job description

Sotera Health, a global leader in sterilization and lab testing, seeks a Quality Assurance Manager for its Salem facility. Reporting to the General Manager, the role oversees all quality functions, ensures compliance with regulatory requirements, and drives corrective actions and process improvements to safeguard patient safety.

Responsibilities include managing audits (FDA/ISO), maintaining quality records, supporting QA/Validations, change control, and coordination with operations for