Quality Manager

Mirion•Oak Ridge, TN

20d

About The Position

The Quality Manager oversees compliance activities for the organization’s Quality Management System and Safety Management System. 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 Quality Manager establishes and audits quality assurance, environmental management, and occupational health and safety procedures to meet ISO and other applicable standards. The role works with Technical, Procurement, Production, and Operations teams on quality, training, audit, software quality assurance, equipment maintenance, inspection, corrective action, reporting, and safety programs. It also includes preparing regulatory submissions and reporting management-system quality to Top Management.

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 thinking.
May be required to lift and move up to 50 pounds.
May be required to sit and stand while performing reader daily functions, and to 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 and 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 needed to meet ISO and other applicable standards.
Oversee and coordinate with Technical, Procurement, and Production teams on the Conditions Adverse to Quality program, Training program, Internal Audit program, and Software Quality Assurance program.
Oversee maintenance and calibration of inspection equipment; conduct random inspections of in-process and finished assemblies; disposition non-conforming materials; and oversee 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 and participate in root-cause analysis and retesting of failures or discrepancies 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 to Top Management on the quality of the management systems.
Serve as liaison for regulatory agencies.
Perform other duties as assigned.