Quality Manager

Mirion Technologies, Inc.; Oak Ridge (TN); On-site; USD 100,000 - 130,000; Full time

Job summary

Mirion Technologies, Inc. is seeking a Quality Manager to oversee QA, EMS, and Safety Management systems, ensuring compliance with ISO standards and government regulations.

You will lead audits, evaluate adverse quality events, and liaise with regulatory agencies to maintain compliance across the organization. The role involves coordinating with Technical, Procurement, and Production teams on various quality programs, managing internal audits, data analysis, and corrective actions, and preparing

Qualifications

• Bachelor’s degree or equivalent in a technical discipline with relevant work experience.
• Prior experience in Quality, Health & Safety, or Manufacturing Management.
• Prior experience with Document Control in a regulated industry.

Responsibilities

• Establish and audit QA, EMS, and OSHAS procedures to meet ISO standards.
• Oversee coordination with Technical team, Procurement, and Production on programs.
• Oversee equipment maintenance, inspection, and disposition of non-conforming materials.
• Manage Internal Audit Program per regulatory requirements.
• Analyze data and report test results 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.
• Monitor safety and environmental regulations and update programs.
• Conduct safety training and track safety metrics.
• Prepare regulatory submissions and annual compliance reports.
• Report to Top Management on quality management systems.
• Other duties as assigned.

Skills

Quality management

Regulatory knowledge

Auditing

Data analysis

Safety

ISO 17025

ISO 9001

Education

Bachelor’s Degree in a technical discipline

Experience in Quality, Health & Safety, or Manufacturing Management

Experience with Document Control in regulated industry

Tools

CAD principles

Job description

Join Mirion in our mission to harness our unrivaled knowledge of ionizing radiation for the greater good of humanity.

Dosimetry Services, a Mirion Medical Company, offers products and services that better the human condition by removing the worry of radiation from the daily routines of those who are occupationally exposed. Delivering Better Tools for Safer Workspaces.

The Quality Manager will oversee all compliance related activities applicable to the organization’s Quality Management system and Safety Management system. This will consist of performing customer and compliance audits, evaluating Conditions Adverse to Quality events, and ensuring that the organization complies to local, State, and government regulations regarding Safety and environmental matters. They will act as the liaison for all regulatory agencies.

JOB RESPONSIBILITIES, DUTIES & CORE FUNCTIONS:

• Establish, formulate, and audit the QA, EMS, and OSHAS procedures necessary for the company to meet ISO standards and other standards that may become a requirement.
• Oversee and liaison with Technical team, Procurement, and Production for programs including but not limited to: Condition Adverse to Quality program, Training program, Internal Audit program, and Software quality assurance program.
• Overseeing of the maintenance and calibration of all inspection equipment, random inspection of in-process and finished assemblies, disposition of all non-conforming materials, & Incoming inspections.
• Oversee Internal Audit Program in compliance with applicable Regulatory requirements.
• Assure appropriate data is efficiently obtained and 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 retest of any 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 safety awareness training at company level.
• 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.
• Other duties as assigned.

REQUIRED EDUCATION, SKILLS, QUALIFICATIONS, & EXPERIENCE

Education

• 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

PREFERRED SKILLS

• 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 with generating and presenting quantitative reports
• Excellent written communication skills and proficient in the use of Excel and/or other tools for the reporting and statistical analysis of data
• Working knowledge of CAD principles
• Ability to read and interpret Safety Data Sheets
• Must be able to work with minimal direct supervision
• Detail-oriented, analytical, and methodical a thinker

PHYSICAL REQUIREMENTS & WORK ENVIRONMENT

Physical Requirements

• May be required to lift and move up to 50 pounds
• May be required to sit and stand while performing reader daily functions
• May be required to bend and reach while performing reader maintenance
• May occasionally work with hazardous materials including chemicals and radioactive materials

• While performing the duties of this job, the employee is sitting at a desk in a cubicle setting or standing to perform reader task

Work Environment

• Climate-controlled facility with medium noise level