Radiation QA & Compliance Leader

Mirion; Oak Ridge (AL); On-site; USD 90,000 - 130,000; Full time

Job summary

Mirion is seeking a Quality Manager for its Dosimetry Services division. You will oversee the QA, EMS, and OSHAS systems, coordinate audits, review adverse quality events, and ensure compliance with local, state, and government regulations regarding safety and environmental matters.

You will liaise with regulators and internal teams to improve product and process quality. The role requires managing internal audits, data analysis, and corrective actions, plus preparing regulatory submissions.

Qualifications

• Bachelor's Degree in a technical discipline or equivalent with relevant work experience.
• Experience in Quality, Health & Safety, or Manufacturing Management.
• Experience with Document Control in a regulated industry.
• Knowledge of ISO 17025 and ISO 9001 preferred.
• Audit experience following ISO 19011 preferred.
• Experience in radiological testing environment preferred.

Responsibilities

• Establish, audit QA/EMS/OSHAS procedures to meet ISO and other standards.
• Liaise with Technical, Procurement, Production for QA programs.
• Oversee calibration of inspection equipment and disposition of non-conforming materials.
• Oversee Internal Audit Program per regulatory requirements.
• Analyze and interpret test data with statistical methods.
• Prepare Lot Qualification Reports with evidence of conformance.
• Investigate root causes and retest failures as needed.
• Ensure corrective actions are tracked and closed timely.
• Stay current with safety and environmental regulations.
• Conduct safety awareness training and track safety metrics.
• Prepare regulatory submissions and reports for top management.

Skills

Audit coordination

Statistical analysis

Quality systems

Regulatory knowledge

Documentation control

Education

Bachelor's degree in a technical discipline

Tools

Excel

Document Control software

Regulatory submissions software

Job description

Mirion is seeking a Quality Manager for its Dosimetry Services division. You will oversee the QA, EMS, and OSHAS systems, coordinate audits, review adverse quality events, and ensure compliance with local, state, and government regulations regarding safety and environmental matters.

You will liaise with regulators and internal teams to improve product and process quality. The role requires managing internal audits, data analysis, and corrective actions, plus preparing regulatory submissions.