Manager Quality Assurance

Reporting to the General Manager, the Quality Assurance (QA) Manager is directly responsible for managing and coordinating all quality functions for the facility. The QA Manager maintains responsibility for all aspects connected with compliance, including the development, analysis and reporting of support data for regulatory agencies and Corporate Quality. In addition, they are responsible for addressing all quality issues in a timely fashion and communicating that information to the site as required. The QA Manager is responsible to assure compliance with all corporate and government procedures and regulations and serves as the Management Representative and Responsible Engineering Manager for the facility.

Responsibilities

• Quality, Regulatory & Safety
• Maintains compliance with all regulatory requirements to include FDA, OSHA, EPA, USDA and NRC as applicable.
• Actively pursues continuous process and quality improvement as measured by internal indices and external audits / reports.
• Coordinates activities relating to determining and reporting causes of non-conformances, as well as implementing corrective actions and process improvements; assist in appropriate retraining.
• Initiates and / or oversees change control process.
• Analysis of facility data for identification of trends and initiation of required actions.
• Coordinates all activities relevant to FDA, ISO, customer, Internal & other regulatory audits.
• Conducts internal compliance audits as required and maintains appropriate records.
• Maintains facility quality records and procedures.
• Coordinates and maintains personnel dosimetry records.
• Coordinates with plant Operations all system requalification activities as applicable.
• Assists Corporate Quality Assurance with special projects and assignments as requested.
• Coordinates facility management reviews.
• Coordinates and maintains facility risk analysis.
• Coordinates environmental monitoring and maintains personnel badge testing records.
• Executes Equivalency and Retrospective Revalidation studies / report where applicable.

Operations

Human Resources

Qualifications

Special Requirements

Training Required

Benefits

Sotera Health offers a competitive benefits package that includes :

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics . LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.

VEVRAA Federal Contractor