Quality Assurance Engineer

Phase2 Technology; Florham Park (NJ); On-site; USD 75,000 - 105,000; Full time

Job summary

Phase2 Technology in Florham Park, NJ, seeks a Quality Engineer to manage design and production relationships, ensuring product integrity and continuous improvement of Nuclear Medicine products throughout their life cycle. You will strengthen the Quality Management System and provide quality support in development and production.

Responsibilities include verifying assemblies to drawings, driving cross-functional improvements with Operations and R&D, leading RCCA investigations, FAI and audits,

Qualifications

• Must have at least four (4) years' experience as a Quality Engineer.
• Minimum of 5 years quality-related work experience.
• Lean/Six Sigma experience; Green/Black Belt preferred.
• Strong RCCA and problem-solving skills with 5-Why, Fishbone, and 8D techniques.
• Knowledge of DFMEA/PFMEA, Control plans, and SPC.
• Ability to trend data and drive leadership decisions.
• Familiar with ISO and FDA standards.
• Able to read mechanical drawings and apply GD&T.
• Experience with FAI.
• Proficient in Excel and Access for metrics.

Responsibilities

• Verify compliance of finished assemblies with drawings.
• Manage design and production relationships to ensure product integrity and improvement.
• Partner across Operations and R&D to drive continuous improvement and reduce risks.
• Provide guidance to Quality Inspectors, conduct product inspections and audits.
• Assist in developing and maintaining QMS procedures and manuals.
• Identify and lead continuous improvement opportunities (Lean, 5S, Mistake Proofing).
• Manage nonconforming material including containment and disposition.
• Analyze and report quality metrics to identify trends and opportunities.
• Lead RCCA for hardware and process issues.
• Review designs to minimize manufacturing risks via controls and inspections.

Skills

Lean Six Sigma

RCCA

Root Cause Analysis

5-Why Analysis

Fishbone Diagram

DFMEA/PFMEA

GD&T

FAI

Excel

Access

Education

Bachelor's degree in Industrial Engineering, Quality/Manufacturing Engineering, Mechanical Engineering, or similar

Tools

Microsoft Excel

Microsoft Access

Job description

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 Statement

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 the Know Your Rights notice from the Department of Labor.