Phase2 Technology
Job Description
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 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
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
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review Know Your Rights notice from the Department of Labor.
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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 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
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
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review Know Your Rights notice from the Department of Labor.
#J-18808-Ljbffr