QA Manager, Sterilization & Compliance

Sotera Health Services, LLC; United States; On-site; USD 92,000 - 149,000; Full time

Benefits offered by this job

Medical, Rx, Dental

Vision, Disability, Life Insurance

401(k) with company match

Paid holidays, vacation and sick time

Job summary

Sotera Health Services, LLC is seeking a Quality Assurance Manager to lead the QA functions at our U.S. facility. The role ensures compliance with FDA, ISO, and other regulatory requirements, and serves as the Management Representative for the site.

You will coordinate audits, drive corrective actions, and report quality data to Corporate Quality. Responsibilities include overseeing change control, data trend analysis, personnel dosimetry coordination, and interaction with Operations to meet

Qualifications

• Minimum BA or BS in a related field.
• Excellent written and verbal communication skills.
• Above average computer skills.

Responsibilities

• Maintain compliance with all regulatory requirements (FDA, OSHA, EPA, USDA, NRC).
• Coordinate internal and external audits and corrective actions.
• Manage and improve non-conformance investigations and CAPAs.
• Lead change control processes and data analysis for trends.
• Supervise QA staff and coordinate with Operations.

Skills

Communication skills

Computer skills

Quality assurance

Leadership potential

Education

BA/BS in related field

Job description

Sotera Health Services, LLC is seeking a Quality Assurance Manager to lead the QA functions at our U.S. facility. The role ensures compliance with FDA, ISO, and other regulatory requirements, and serves as the Management Representative for the site.

You will coordinate audits, drive corrective actions, and report quality data to Corporate Quality. Responsibilities include overseeing change control, data trend analysis, personnel dosimetry coordination, and interaction with Operations to meet