Mirion Technologies · 9 hours ago
Quality Assurance Engineer
Florham Park, NJ
Full-time
Onsite
Mid, Senior Level
5+ years expMirion Technologies is focused on improving manufacturing performance and customer satisfaction in Nuclear Medicine products. The Quality Engineer will manage design and production relationships, improve the Quality Management System, and provide quality support in development and production environments.
Medical Device
Responsibilities
Verify compliance of finished assemblies with drawing requirements based on customer and industry standards
Manage design and production relationships to ensure product integrity and continuously improve manufacturing performance
Partner cross-functionally within Operations as well as with R&D to drive continuous improvement, eliminate known issues, and reduce potential risks
Provide guidance to Quality Inspectors, conduct product inspections, and process audits
Assist in developing, implementing, and maintaining procedures and manuals for the Quality Management System
Identify and lead Continuous Improvement opportunities, such as Lean Process Improvements (elimination of waste), 5S Improvements, and Mistake Proofing
Manage nonconforming material including containment/communication, dispositioning, approval, and timely closure
Analyze and report on quality metrics (ex: Quality KPIs) to identify trending issues and develop improvement opportunities
Participate in and drive adequate Root Cause & Corrective Action (RCCA) for necessary hardware and process issues
Review and analyze product designs and critical requirements to identify and minimize potential manufacturing risks through mistake proofing, process controls and inspection methods
Qualification
Required
Must have at least four (4) years' experience as a Quality Engineer
Minimum of 5 years Quality related work experience
Exceptional problem-solving skills are a must
Working knowledge and experience in effective problem-solving methods for Root Cause / Corrective Action (RCCA) and investigative techniques such as 5-Why analysis, Fishbone Diagram, 8D method, and data analysis
Basic understanding of risk assessment techniques such as DFMEA/PFMEA, Control plans, and SPC
Ability to perform trend analysis and transform data into information to assist leadership into making impactful decisions
Familiar with ISO and FDA standards
Capable of interpreting mechanical drawings (machined, cast, and injection molded parts)
Working knowledge and understanding of GD&T (Geometric Dimensioning and Tolerancing)
Experience with First Article Inspections (FAI)
Proficient in data automation and metric development through applications such as Microsoft Excel and Access
Proficient in the use of manual and visual inspection equipment
Bachelor's degree in either Industrial Engineering, Quality/Manufacturing Engineering, Mechanical Engineering, or similar technical field
Preferred
Lean and/or Six Sigma experience (Six Sigma Greenbelt or Blackbelt certified is preferred)
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