Quality Assurance Engineer

1 week ago

Florham Park, United States Mirion Technologies Full time

Quality Assurance Engineer Join to apply for the Quality Assurance Engineer role at Mirion Technologies The Quality Engineer is responsible for managing design and production relationships to ensure product integrity and continuously improve manufacturing performance and customer satisfaction throughout the life cycle of Nuclear Medicine products.

Responsibilities

also include improving the Quality Management System, and general quality support in both development and production environments. Key Areas of 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.

Skills

And Experience Must have at least four (4) years’ experience as a Quality Engineer. Minimum of 5 years Quality related work experience. Lean and/or Six Sigma experience (Six Sigma Greenbelt or Blackbelt certified is preferred). 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 in 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. Academic Requirements Bachelor’s degree in either Industrial Engineering, Quality/Manufacturing Engineering, Mechanical Engineering, or similar technical field Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Engineering and Information Technology Industries Measuring and Control Instrument Manufacturing #J-18808-Ljbffr

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