Manager Quality Assurance

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry.

With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality.

We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Reporting to the General Manager, the Quality Assurance (QA) Manager is directly responsible for managing and coordinating all quality functions for the facility.

He/She 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, he/she is responsible for addressing all quality issues in a timely fashion and communicating that information to the site as required.

 The Quality Assurance 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 Revalidatio...