Overview
On Site
Full Time
Skills
Product Engineering
Regulatory Compliance
ISO 9000
DMAIC
Product QA
Trend Analysis
Auditing
Organized
Quality Management
Product Development
Risk Management
FMEA
Design Of Experiments
Statistical Process Control
Process Modeling
Minitab
Microsoft Power BI
Job Details
Role Overview:
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:
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.
- 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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