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Quality Engineer
4 months ago
SUMMARY
The PCB (Printed circuit board) 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.
RESPONSIBILTIES
- Verify compliance of finished assemblies with drawing requirements based on customer and industry standards, ex IPC-610 / J-STD 001
- 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.
QUALIFICATIONS
- Bachelor's degree in either Industrial Engineering, Quality/Manufacturing Engineering, Mechanical Engineering, or similar technical field
- 4 years’ experience as a Quality Engineer in a PCBA and Mechanical EMS (Electronic Manufacturing Services) Environment Required.
- Minimum of 5 years Quality related work experience
- Exceptional problem-solving skills are a must.
- Preferred Certified IPC610, J-STD 001 trainer with ability to train other employees
- Lean and/or Six Sigma experience (Six Sigma Greenbelt or Blackbelt certified is preferred).
- Familiar with IPC, ISO, and FDA standards.
- Working knowledge and experience in effective problem-solving methods for Root Cause / Corrective Acton (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.
- 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.
