Quality Assurance Manager

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. 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

• Coordinates/executes process validations and calibrations where required.
• Reviews and releases batch records for processed materials.
• Assists where necessary in establishing departmental objectives to meet overall facility goals.

Human Resources

• Communicates the company quality policy and values, motivating and sensitizing employees to the critical nature of our service.
• Involved in the hiring, retention, motivation and development of qualified personnel in QA/Validations positions, if applicable.
• Assists with new employee orientation, job function, GMP, safety and developmental training to employees as required by Standard Operating Procedures, Certification programs, corporate requirements and customer service initiatives.
• Interacts with all functions within the plant.
• Provides all subordinates with clear and measurable objectives.
• Maintains all quality related training programs.
• Assists with other tasks as assigned by Supervisor.
• SUPERVISION GIVEN: May supervise the work of others.

Qualifications

• Minimum BA or BS in a related field
• Three (3) to five (5) years of quality assurance experience in the medical services/products area or, extensive quality science training (e.g., ASQ), with a proven understanding of people’s motivation and proven leadership potential.
• Comparable experience in the food industry is desirable (in lieu of medical experience) for food irradiation facilities.
• Excellent written and verbal communication skills.
• Above average computer skills.

Special Requirements

• Must be medically approved for respirator use (EO)
• Must be able to tolerate exposure to high temperature and high humidity (120F and 60% RH for 20 minutes) (EO)

Training Required

• Must complete all required training for a “Quality Assurance Manager” outlined in the training manual.

Benefits

Sotera Health offers a competitive benefits package that includes:

• Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
• 401(k) program with Company match that immediately vests
• Paid holidays, vacation and sick time
• Free financial planning assistance
• Paid parental leave
• Education assistance
• Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
• Employee Assistance Program (EAP)

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 U.S. 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

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.