More jobs:
Product Quality Engineer
Job in
Round Lake, Lake County, Illinois, 60073, USA
Listed on 2025-12-30
Listing for:
Katalyst Healthcares and Lifesciences
Full Time
position Listed on 2025-12-30
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Summary
The Product Quality Engineer (PQE) display basic understanding of the Product Engineering and Quality Management System concepts. Utilizes sound statistical and engineering techniques/tools to investigate non-conformances. As Quality Reviewer, performs document reviews to support design and labeling change controls. Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.
A functional understanding of FDA, ISO and Baxter Quality systems is also required.
- Utilizes DMAIC tools to investigate non-conformances and participates in (CAPA)-related activities, including CAPA ownership as required.
- Utilizes engineering product development/process knowledge to solve straight forward problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Molding, SPC)
- Performs standard engineering assignments to support change controls, new product development, and assists cross-functional teams in identification of risks.
- Supports product testing to ensure product conformance to specifications.
5. Understands principles of complaint handling process and supports complaint investigations. - Conducts complaint trend analysis and analyzes data from various sources (Non-Conformances, Field
-Corrective Actions, and Complaints) to drive decisions. - Facilitates small project teams as needed to accomplish team objectives
- Supports Quality internal and external audits as required.
- Degree in Engineering, with a minimum of 3 years’ experience in a related environment.
- Display basic understanding of Quality Management System.
- Display a technical understanding of engineering and product development principles and procedures.
- Familiarity with Minitab, Power BI desired.
- Display basic understanding of change controls and risk management principles.
- Experience in working with cross-functional teams, including technical and non-technical work.
- bility to organize and present technical information with minimal assistance.
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