Mirion Technologies · 10 hours ago
Senior Quality Engineer
Oak Ridge, TN
Full-time
Onsite
Senior Level
5+ years expMirion Technologies is seeking a Senior Quality Engineer responsible for implementing, monitoring, and improving the Quality Management System (QMS) to enhance organizational productivity and customer satisfaction. The role includes data analysis, corrective action oversight, and supplier qualification, ensuring compliance with QA policies and procedures.
Medical Device
Responsibilities
Provide QA support and expertise to project teams
Ensure compliance with QA policies, procedures, and contract requirements
Collect and analyze non-conformance data; prepare quality reports and presentations
Investigate and document non-conformances across customers, internal processes, and suppliers
Determine root causes and implement corrective actions; evaluate effectiveness
Participate in supplier selection, qualification, and improvement activities
Oversee inspection and testing to ensure product compliance
Lead continuous improvement projects for QA processes
Coordinate annual calibration of Measuring and Test Equipment
Interface with customer QA personnel and support audits
Guide and coordinate QA activities for projects and daily operations
Perform other QA-related tasks as needed (e.g., inspections, contract review, documentation, problem-solving)
Safety: Follow all site safety rules; report safety incidents and opportunities for improvement
Quality: Demonstrate knowledge of ISO 9001:2015, 45001:2018, and 17025:2017 standards; ensure QMS compliance; conduct internal audits and corrective actions
Corporate/Site: Complete required compliance training; adhere to site regulations and company policies
Qualification
Required
Knowledge of Quality Assurance principles, analysis tools, and engineering techniques is essential: must be ready to step into the job with minimum training
Proficiency in ISO 9001 quality system requirements and application in a manufacturing environment
Experience with supplier selection and qualification
Excellent written and verbal communication skills
Proficient computer skills including Excel, Word, and PowerPoint
Proficient in measurement techniques
2-year quality degree, or a 2-year technical degree in Electrical Engineering, Mechanical Engineering, Industrial Engineering, Nuclear Engineering or related field OR very exceptional work experience may be considered as a substitute for formal education degree
5 years' experience as a quality engineer or quality assurance representative
Preferred
Experience with ISO 45001 and 17025 quality system requirements
Experience with APQP core tools
Experience with 10 CFR 50 Part B Quality Program and 10 CFR 830.120
Experience with ASME NQA-1 and NQA-2, Subpart 2.7, Software Quality Assurance
Previous experience as a quality manager
Company
Mirion Technologies
At Mirion Technologies, we advance radiation safety and empower the next wave of critical innovation.
1001-5000 employees
H1B Sponsorship
Mirion Technologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase