Director Quality Radiation

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

Job summary

An established industry player is seeking a Director of Quality Assurance to oversee compliance and quality systems across its facilities. This pivotal role involves ensuring adherence to global regulations, leading quality improvement initiatives, and providing technical support to management. The ideal candidate will possess extensive experience in quality assurance within the pharmaceutical or medical device sectors and demonstrate exceptional problem-solving and communication skills. Join a forward-thinking company dedicated to safeguarding global health and making a significant impact in the healthcare industry.

Benefits

Medical, Rx, Dental, Vision Insurance

401(k) with Company Match

Paid Holidays and Vacation

Education Assistance

Employee Assistance Program (EAP)

Paid Parental Leave

Flexible Spending Accounts

Qualifications

• Experience in quality assurance and regulatory compliance in the healthcare sector.
• Strong background in managing quality systems and leading audits.

Responsibilities

• Ensure compliance with global regulatory bodies and lead quality improvement programs.
• Support facilities during audits and develop training programs for QA staff.

Skills

Quality Assurance

Regulatory Compliance

Auditing

CAPA Performance

Problem-solving

Communication Skills

Organizational Skills

Education

Bachelor’s Degree in Quality or related field

8 years of experience in quality/sterilization

3 years in management function

Tools

Quality Management System

ISO Standards

FDA Regulations

Job description

Reporting to the VP Global QA, the Director of Quality Assurance provides technical, compliance, and regulatory guidance to processing facilities has responsibility for the quality oversight of Sterigenics’ quality system implementation and execution.

Requires travel up to 30%. Some international travel is expected.

Duties and Responsibilities

• Ensure compliance with global regulatory bodies, including but not limited to FDA, ISO, MHLW/JPAL, USDA and MHRA.
• Track and understand all applicable Quality regulations that impact Sterigenics operations.
• Work with local regulatory agencies on new and existing permits, licenses and regulations that impact our operations.
• Lead programs to ensure continuous operational quality improvement as measured by quality metrics and reported to the appropriate levels of management.
• Support facilities during internal and external audits and in response to internal and external audit findings.
• Participate in Management Reviews and monthly data analysis meetings.
• Provide technical support regarding the quality management system to senior staff and facility management.
• Ensure the consistent application and maintenance of the Quality Management System across the facilities. Participate or lead the development, review, and approval of appropriate levels of the system.
• Represent Sterigenics on national standards groups as appropriate.
• Ensure active participation by the Quality organization with Operations in establishing best- demonstrated practices.
• Work with customers to resolve problems and achieving productivity gains wherever possible.
• Work with Operations, Sales and Engineering to justify and implement capital projects and engineering/process changes as required. The responsibility for a successful project includes meeting applicable regulatory and quality system requirements.
• Work with the applicable sales representatives to support the customers’ needs and to resolve issues in a timely manner.
• Participate in customer meetings presenting Sterigenics quality processes, projects and results.
• Participate in the hiring and training of QA staff with the potential to advance into higher positions.
• Develop and improve training programs that include job function, as well as interpersonal skills and personal development training.
• Provide input for Quality Manager appraisals to the appropriate General Manager or VP of Operations.
• Provide input for all disciplinary actions taken on all regional QA employees.
• Prepare and understand, as required, budgets and financial plans for the Quality organization. Meet budget responsibilities in QA operating plan.
• Work with Operations to meet or exceed the fiscal goals of the organization.

Supervision Given

• Directly Supervised by the Global VP Of Quality Assurance. Indirectly reports to the Regional VP of Operations.
• The Director of Quality Assurance has indirect responsibility for the QA Managers within the region.

Education, Experience, and Skills Required

• Bachelor’s Degree or 8 years of experience in quality / sterilization (or related field).
• Relevant experience in management function (minimum 3 years).
• Proficiency in the pharmaceutical / medical device industry is preferred.
• Proficiency in auditing and being audited.
• Proficiency in CAPA performance.
• Experience with Quality Systems and applying Regulatory Standards.
• Experience with ISO and FDA regulations.
• Must be able to read, write and speak English.
• Excellent organizational skills.
• Excellent communication skills on all levels.
• Efficient, accurate, works according to plan.
• Flexible.
• Problem-solving attitude.
• High profile commitment to quality.

Special Requirements

• Requires travel up to 30%.
• Some international travel is expected.

Training Required

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

Salary Range: $127,000 – $216,000 per year; depending on experience.

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 ContractorThe 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 8 of the top 10 global pharmaceutical companies.

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. Learn more about Sotera Health at soterahealth.com.

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