Director Quality Radiation

Sterigenics U.S., LLC in; Oak Brook (IL); On-site; USD 127,000 - 216,000; Full time

Job summary

A leading company in the sterilization industry seeks a Director of Quality Assurance to oversee quality systems and ensure compliance with regulations. The role involves managing quality metrics, supporting audits, and collaborating with operations to enhance practices. The ideal candidate will have a strong background in quality assurance, regulatory knowledge, and leadership experience, with a commitment to quality and problem-solving.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Paid holidays

Vacation

Sick leave

Education assistance

Employee Assistance Program (EAP)

Qualifications

• 8 years in quality/sterilization or related field.
• Minimum 3 years of management experience.
• Experience in pharmaceutical/medical device industry preferred.

Responsibilities

• Ensure compliance with global regulatory bodies like FDA, ISO.
• Lead programs for continuous operational quality improvement.
• Support facilities during audits and respond to findings.

Skills

Organizational Skills

Communication Skills

Problem-Solving

Education

Bachelor's Degree

Tools

Quality Systems

Auditing

CAPA

Job description

Director of Quality Radiation (Finance)

Reporting to the VP of Global QA, the Director of Quality Assurance provides technical, compliance, and regulatory guidance to processing facilities. This role is responsible for overseeing the implementation and execution of Sterigenics' quality systems.

Requires travel up to 30%, including some international travel.

Duties and Responsibilities

1. Ensure compliance with global regulatory bodies such as FDA, ISO, MHLW/JPAL, USDA, and MHRA.
2. Monitor and understand all applicable quality regulations impacting operations.
3. Collaborate with local regulatory agencies on permits, licenses, and regulations.
4. Lead programs for continuous operational quality improvement based on quality metrics.
5. Support facilities during audits and respond to findings.
6. Participate in management reviews and data analysis meetings.
7. Provide technical support for the quality management system to senior staff and facility management.
8. Maintain consistent application of the Quality Management System across facilities.
9. Represent Sterigenics on national standards groups as appropriate.
10. Collaborate with Operations to establish best practices.
11. Work with customers to resolve problems and improve productivity.
12. Support capital projects and process changes, ensuring regulatory and quality compliance.
13. Assist sales in supporting customer needs and resolving issues.
14. Participate in customer meetings to present quality processes and results.
15. Contribute to hiring, training, and developing QA staff.
16. Develop and improve training programs.
17. Provide input for performance appraisals and disciplinary actions.
18. Manage budgets and financial plans for the Quality organization.
19. Work with Operations to meet fiscal goals.

Supervision Given

1. Directly supervised by the Global VP of Quality Assurance; indirectly reports to the Regional VP of Operations.
2. Indirect responsibility for regional QA Managers.

Qualifications

• Bachelor's Degree or 8 years of experience in quality/sterilization or related field.
• Minimum 3 years of management experience.
• Experience in pharmaceutical/medical device industry preferred.
• Proficiency in auditing, CAPA, and Quality Systems.
• Knowledge of ISO and FDA regulations.
• Fluent in English (reading, writing, speaking).
• Strong organizational and communication skills.
• Problem-solving attitude and high commitment to quality.

Special Requirements

• Requires travel up to 30%, including international travel.

Training

• Completion of all required training for a "Quality Assurance Director".

Compensation & Benefits

Salary range: $127,000 - $216,000 annually, depending on experience.

• Comprehensive benefits including medical, dental, vision, disability, life insurance, HSA, FSA.
• 401(k) with company match.
• Paid holidays, vacation, sick leave.
• Financial planning, parental leave, education assistance.
• Voluntary benefits: critical illness, accident, hospital indemnity, pet insurance.
• Employee Assistance Program (EAP).

Equal Opportunity Statement

All qualified applicants will receive consideration without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. We encourage underrepresented groups to apply.

About Sotera Health

Sotera Health is committed to safeguarding global health, providing sterilization and lab testing services worldwide. We operate across 64 facilities with over 3,000 employees, serving top medical device and pharmaceutical companies globally. Learn more at soterahealth.com.