QA Manager: Regulatory Excellence & Process Improvement

Sterigenics U.S., LLC in; Marion (AR); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Medical, Rx, Dental, Vision

401(k) with company match

Paid holidays, vacation and sick time

Job summary

Sotera Health's Sterigenics U.S., LLC is seeking a Quality Assurance Manager (Project Management) to lead the facility's QA, regulatory, and quality-improvement efforts. Reporting to the General Manager, you will coordinate all quality functions and ensure compliance with FDA, OSHA, ISO, and other regulators.

You will drive data analysis, change control, audits, training, and risk assessments while supervising QA staff and interfacing with operations.

Qualifications

• BA/BS in related field as minimum.
• 3–5 years of QA experience in medical services/products or equivalent.
• Excellent written and verbal communication skills.

Responsibilities

• Manage quality, regulatory and safety functions for the facility.
• Coordinate FDA/ISO audits and regulatory compliance activities.
• Lead corrective actions and process improvements with retraining where needed.
• Oversee change control processes and data reporting for regulatory agencies.
• Maintain facility quality records and train personnel on quality systems.

Skills

QA leadership

Regulatory knowledge

Data analysis

Communication skills

Education

BA/BS in related field

Job description

Sotera Health's Sterigenics U.S., LLC is seeking a Quality Assurance Manager (Project Management) to lead the facility's QA, regulatory, and quality-improvement efforts. Reporting to the General Manager, you will coordinate all quality functions and ensure compliance with FDA, OSHA, ISO, and other regulators.

You will drive data analysis, change control, audits, training, and risk assessments while supervising QA staff and interfacing with operations.