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Quality Engineer PCB
2 months ago
Job Description: PCB Quality Engineer
The PCB Quality Engineer ensures product integrity and enhances manufacturing performance and customer satisfaction for medical instruments. Responsibilities include improving the Quality Management System and providing quality support in development and production.
Key Responsibilities:
- Ensure finished assemblies comply with IPC-610 / J-STD 001 standards.
- Manage design and production relationships to maintain product integrity and improve performance.
- Collaborate cross-functionally with Operations and R&D to drive continuous improvement and mitigate risks.
- Guide Quality Inspectors and conduct product inspections and process audits.
- Develop, implement, and maintain Quality Management System procedures and manuals.
- Identify and lead Continuous Improvement opportunities like Lean Process Improvements, 5S, and Mistake Proofing.
- Manage nonconforming material, including containment, disposition, approval, and timely closure.
- Analyze and report quality metrics to identify trends and improvement opportunities.
- Drive Root Cause & Corrective Action (RCCA) for hardware and process issues.
- Review and analyze product designs to minimize manufacturing risks through mistake proofing, process controls, and inspection methods.
Skills and Experience:
- Minimum of 4 years as a Quality Engineer in PCBA and Mechanical EMS environments.
- Certified IPC610, J-STD 001 trainer preferred.
- At least 5 years of quality-related work experience.
- Experience in Lean and/or Six Sigma (Greenbelt or Blackbelt preferred).
- Strong problem-solving skills and experience with RCCA, 5-Why analysis, Fishbone Diagram, 8D method, and data analysis.
- Understanding of DFMEA/PFMEA, Control Plans, and SPC.
- Ability to perform trend analysis and present data to assist leadership decisions.
- Familiarity with IPC, ISO, and FDA standards.
- Ability to interpret mechanical drawings and understand GD&T.
- Experience with First Article Inspections (FAI).
- Proficient in data automation and metric development using Microsoft Excel and Access.
- Skilled in using manual and visual inspection equipment.
Academic Requirements:
- Bachelor's degree in Industrial Engineering, Quality/Manufacturing Engineering, Mechanical Engineering, or a related technical field.