Senior Quality Assurance Leader - Regulatory Compliance

Sterigenics U.S., LLC; Atlanta (GA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

401(k) matching

Paid holidays and vacation

Education assistance

Parental leave

Employee Assistance Program

Job summary

Sterigenics U.S. LLC is seeking a Quality Assurance Manager to oversee all quality functions at the facility, ensuring compliance with corporate and governmental procedures.

The role includes data analysis for regulatory reporting, managing non-conformances, and communicating issues to the site leadership. The ideal candidate will have a BA/BS, 3–5 years in QA within medical devices or related sectors, strong communication skills, and experience with QA systems and audits.

Qualifications

• Minimum BA or BS in a related field.
• Three to five years of quality assurance experience in medical services/products.
• ASQ or extensive quality science training.
• Excellent written and verbal communication skills.
• Above average computer skills.

Responsibilities

• Maintains compliance with regulatory requirements (FDA, OSHA, EPA, USDA, NRC).
• Pursues continuous process and quality improvement.
• Coordinates non-conformances and corrective actions.
• Oversees change control processes.
• Coordinates audits with FDA, ISO, customers and other regulators.

Skills

Quality assurance

Leadership

Regulatory knowledge

Communication skills

Computer skills

Education

Bachelor's degree in related field

Job description

Sterigenics U.S. LLC is seeking a Quality Assurance Manager to oversee all quality functions at the facility, ensuring compliance with corporate and governmental procedures.

The role includes data analysis for regulatory reporting, managing non-conformances, and communicating issues to the site leadership. The ideal candidate will have a BA/BS, 3–5 years in QA within medical devices or related sectors, strong communication skills, and experience with QA systems and audits.