What are the responsibilities and job description for the Product Quality Engineer position at Katalyst CRO?
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.
Roles & Responsibilities
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.
Roles & Responsibilities
- 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.
- Ability to organize and present technical information with minimal assistance.