Quality Manager

Mirion Technologies • Oak Ridge, TN

9d

About The Position

The Quality Manager oversees compliance activities for the organization’s Quality Management and Safety Management systems. The role includes conducting customer and compliance audits, evaluating Conditions Adverse to Quality events, ensuring compliance with local, state, and government safety and environmental regulations, and serving as the liaison for regulatory agencies. The position reports on management-system quality to Top Management.

The Quality Manager establishes and audits QA, EMS, and OSHAS procedures needed to meet ISO and other applicable standards. The role works with Technical, Procurement, and Production teams on quality and safety programs, including corrective actions, training, internal audits, and software quality assurance. It also oversees inspection equipment maintenance and calibration, inspections, non-conforming material disposition, statistical analysis of test data, lot qualification reports, root-cause investigations, regulatory submissions, and safety awareness training.

The work is performed in a climate-controlled facility with a medium noise level. Duties may involve sitting at a desk in a cubicle setting or standing to perform reader tasks, and occasionally working with hazardous materials, including chemicals and radioactive materials.

Requirements

• Bachelor’s degree in a technical discipline or equivalent and relevant work experience.
• Prior experience in Quality, Health & Safety, or Manufacturing Management.
• Prior experience with Document Control in a regulated industry.
• Ability to work with minimal direct supervision.
• Detail-oriented, analytical, and methodical approach to work.
• May be required to lift and move up to 50 pounds.
• May be required to sit and stand while performing reader daily functions and bend and reach while performing reader maintenance.
• May occasionally work with hazardous materials, including chemicals and radioactive materials.

Nice To Haves

• Prior experience in Quality, Health & Safety, or Manufacturing fields.
• Prior experience working in a radiological test environment.
• Sound knowledge of regulatory requirements, including ISO 17025 and/or ISO 9001.
• Prior audit experience following ISO 19011.
• Experience generating and presenting quantitative reports.
• Excellent written communication skills.
• Proficiency in Excel and/or other tools for reporting and statistical analysis of data.
• Working knowledge of CAD principles.
• Ability to read and interpret Safety Data Sheets.

Responsibilities

• Establish, formulate, and audit QA, EMS, and OSHAS procedures necessary to meet ISO and other applicable standards.
• Coordinate with Technical, Procurement, and Production teams on programs including Conditions Adverse to Quality, training, internal audits, and software quality assurance.
• Oversee maintenance and calibration of inspection equipment, random inspections of in-process and finished assemblies, disposition of non-conforming materials, and incoming inspections.
• Oversee the Internal Audit Program in compliance with applicable regulatory requirements.
• Obtain, review, analyze, and correlate test data using statistical techniques.
• Author Lot Qualification Reports with sufficient detail and objective evidence to demonstrate conformance.
• Investigate failures or discrepancies and participate in root-cause analysis and retesting when required.
• Ensure company corrective actions are assigned, completed, verified, and closed in a timely manner.
• Review and stay current with applicable safety and environmental regulations.
• Conduct company-level safety awareness training.
• Work with Operations to establish and track safety metrics.
• Prepare and submit required regulatory submissions, including annual compliance reports.
• Report on the quality of management systems to Top Management.
• Serve as liaison for regulatory agencies.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager