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PCB Quality Assurance Engineer
2 months ago
The PCB Quality Assurance Engineer plays a crucial role in overseeing the relationships between design and production teams to guarantee product quality and enhance manufacturing efficiency and customer satisfaction throughout the lifecycle of Nuclear Medicine products.
Core Responsibilities:
- Ensure that finished products comply with specifications and standards, including IPC-610 and J-STD 001.
- Facilitate collaboration between design and production to uphold product quality and drive improvements in manufacturing processes.
- Work cross-functionally with Operations and R&D to foster continuous enhancements, resolve existing challenges, and mitigate potential risks.
- Guide Quality Inspectors, perform product evaluations, and conduct process audits.
- Assist in the creation, implementation, and upkeep of the Quality Management System procedures and documentation.
- Identify and spearhead Continuous Improvement initiatives, including Lean Process Improvements, 5S methodologies, and Mistake Proofing strategies.
- Oversee nonconforming materials, including containment, communication, disposition, and timely resolution.
- Analyze quality metrics to identify trends and propose improvement strategies.
- Engage in Root Cause and Corrective Action (RCCA) processes for hardware and procedural issues.
- 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.
- Preferred certification as an IPC610 and J-STD 001 trainer with the capability to educate others.
- 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, with knowledge of effective techniques for Root Cause and Corrective Action (RCCA) and investigative methods such as 5-Why analysis and Fishbone Diagrams.
- Basic understanding of risk assessment methods including DFMEA/PFMEA, Control Plans, and Statistical Process Control (SPC).
- Ability to conduct trend analysis and convert data into actionable insights for leadership decision-making.
- Familiarity with IPC, ISO, and FDA regulations.
- Proficient in interpreting mechanical drawings for various manufacturing processes.
- Understanding of Geometric Dimensioning and Tolerancing (GD&T).
- Experience with First Article Inspections (FAI).
- Skilled in data automation and metric development using tools like Microsoft Excel and Access.
- Proficient in manual and visual inspection techniques.
Educational Background:
- Bachelor's degree in Industrial Engineering, Quality/Manufacturing Engineering, Mechanical Engineering, or a related technical discipline.