Quality Assurance Engineer

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