Quality Assurance Engineer: Drive Improvement & Compliance

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

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,