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Electronics Quality Engineer

2 months ago

Florham Park, New Jersey, United States Mirion Technologies (Capintec), Inc. Full time
Job Overview

The PCB Quality Assurance Engineer plays a crucial role in overseeing the integrity of product design and production processes, ensuring high standards of quality throughout the lifecycle of Nuclear Medicine products. This position is essential for enhancing the Quality Management System and providing comprehensive quality support in both development and manufacturing settings.

Primary Responsibilities:

  • Ensure finished assemblies comply with design specifications and industry standards, including IPC-610 and J-STD 001.
  • Foster collaboration between design and production teams to maintain product integrity and enhance manufacturing efficiency.
  • Work cross-functionally with Operations and R&D to promote continuous improvement, resolve existing issues, and mitigate potential risks.
  • Guide Quality Inspectors, perform product evaluations, and conduct process audits.
  • Assist in the creation, implementation, and upkeep of procedures and documentation for the Quality Management System.
  • Identify and spearhead Continuous Improvement initiatives, such as Lean Process Improvements, 5S methodologies, and Mistake Proofing strategies.
  • Oversee nonconforming materials, including containment, communication, disposition, and resolution processes.
  • Analyze quality metrics to identify trends and develop strategies for improvement.
  • Engage in Root Cause and Corrective Action (RCCA) processes for hardware and procedural challenges.
  • Review product designs and critical specifications to minimize manufacturing risks through effective controls and inspection techniques.

Qualifications and Skills:

  • A minimum of four (4) years of experience as a Quality Engineer in a PCBA and Mechanical EMS environment.
  • Certification as an IPC610 and J-STD 001 trainer is preferred.
  • At least five years of experience in quality-related roles.
  • Experience with Lean and/or Six Sigma methodologies; certification as a Six Sigma Greenbelt or Blackbelt is advantageous.
  • Strong problem-solving abilities and familiarity with effective techniques for Root Cause and Corrective Action (RCCA), including 5-Why analysis and Fishbone Diagrams.
  • Basic knowledge of risk assessment methods such as DFMEA/PFMEA, Control Plans, and Statistical Process Control (SPC).
  • Ability to analyze trends and convert data into actionable insights for leadership decision-making.
  • Familiarity with IPC, ISO, and FDA regulations.
  • Proficient in interpreting mechanical drawings and understanding GD&T (Geometric Dimensioning and Tolerancing).
  • Experience with First Article Inspections (FAI).
  • Skilled in data automation and metric development using tools like Microsoft Excel and Access.
  • Experienced in utilizing manual and visual inspection tools.

Educational Background:

  • Bachelor's degree in Industrial Engineering, Quality/Manufacturing Engineering, Mechanical Engineering, or a related technical discipline.