Product Quality Engineer

Company : Katalyst Healthcares & Life Sciences

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 

• 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.

Education & Experience

• 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.

Apply Online