Product Quality Engineer

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The Product Quality Engineer (PQE) displays basic understanding of 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 straightforward 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.
• 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.

Associate

Contract

Quality Assurance

Pharmaceutical Manufacturing

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