Quality Assurance Manager - Regulatory Leader

Sterigenics U.S., LLC; Salem (MA); Presencial; USD 92.000 - 149.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Rx, Dental, Vision, Disabilit

401(k) with Company match

Paid holidays, vacation and sick time

Parental leave

Education assistance

EAP

Descripción de la vacante

Sotera Health is seeking a Quality Assurance Manager to lead the QA program at the facility and ensure regulatory and corporate compliance. You will coordinate audits, drive process improvements, and manage quality records and training across the site.

Reporting to the General Manager, you will oversee change control, data reporting to regulators, and QA-related personnel, with responsibilities spanning FDA, ISO, and customer requirements.

Formación

• BA or BS in a related field.
• 3–5 years of QA experience in medical services/products or extensive quality science training (ASQ).
• Food industry QA experience is desirable (for food irradiation facilities).
• Excellent written and verbal communication skills.
• Above average computer skills.

Responsabilidades

• Maintain quality, regulatory and safety compliance across the facility.
• Coordinate audits with FDA, ISO, customer and regulatory bodies; drive corrective actions.
• Lead change control processes and data analysis for quality improvements.
• Maintain quality records, training programs and dosimetry/validation activities.
• Supervise QA-related activities and mentor staff as required.

Conocimientos

Quality assurance

Regulatory compliance

Leadership

Written & verbal communication

Computer skills

Educación

BA/BS in related field

Herramientas

ASQ training

Descripción del empleo

Sotera Health is seeking a Quality Assurance Manager to lead the QA program at the facility and ensure regulatory and corporate compliance. You will coordinate audits, drive process improvements, and manage quality records and training across the site.

Reporting to the General Manager, you will oversee change control, data reporting to regulators, and QA-related personnel, with responsibilities spanning FDA, ISO, and customer requirements.