Product Quality Engineer II

Company : Katalyst Healthcares & Life Sciences

Job Summary:
The Product Quality Engineer (PQE II) will support product engineering and the Quality Management System, leading investigations, supporting change controls, and ensuring compliance with FDA, ISO, and internal quality systems.

Key Responsibilities:

• Use DMAIC, statistical methods, and engineering tools to investigate non-conformances.
• Participate in and own CAPAs as needed.
• Support design & labeling change controls and new product development.
• Perform and support product testing to ensure conformance to specifications.
• Support complaint handling and investigations.
• Conduct complaint trend analysis using data from Company, field actions, and complaints.
• Support internal & external audits.
• Facilitate small project teams to achieve quality and project objectives.
• Present technical information in a clear, organized way to cross-functional teams.

Qualifications:

• Engineering degree with 3+ years of experience in a related environment.
• Working knowledge of Quality Management Systems.
• Understanding of engineering principles, product development, and risk management.
• FMEA, DOE, SPC, process modeling
• Minitab and Power BI (preferred).
• Experience working with cross-functional teams (technical & non-technical).
• Strong ability to organize and present technical information.

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