QA Manager: Regulatory & Process Excellence in Sterilization

Sotera Health Company; Marion (NC); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical benefits

401(k) with company match

Paid time off

Parental leave

Education assistance

EAP

Voluntary benefits including Critical-

Pet Insurance

Job summary

Sotera Health Company is seeking a Quality Assurance Manager to oversee all quality functions at the Marion facility. The role involves ensuring compliance with FDA, OSHA, EPA, USDA, and NRC requirements while driving continuous improvement in processes and data reporting.

You will lead audits, manage change control, maintain quality records, and coordinate with Operations, HR and Corporate Quality to address issues promptly and train staff.

Qualifications

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

Responsibilities

• Maintain compliance with regulatory requirements including FDA, OSHA, EPA, USDA and NRC.
• Pursue continuous process and quality improvement as measured by audits and internal metrics.
• Coordinate activities to determine causes of non-conformances and implement corrective actions.
• Oversee change control processes and document appropriately.
• Analyze facility data to identify trends and initiate corrective actions.
• Coordinate audits with FDA, ISO, customers and other regulators; prepare records.
• Maintain facility quality records and procedures; supervise QA staff when applicable.
• Assist with training and development of QA/Validations personnel.

Skills

Leadership

Quality Assurance

Communication skills

Computer skills

Education

Bachelor's degree in a related field

Job description

Sotera Health Company is seeking a Quality Assurance Manager to oversee all quality functions at the Marion facility. The role involves ensuring compliance with FDA, OSHA, EPA, USDA, and NRC requirements while driving continuous improvement in processes and data reporting.

You will lead audits, manage change control, maintain quality records, and coordinate with Operations, HR and Corporate Quality to address issues promptly and train staff.