Quality Manager
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