Quality Engineer

La Porte, Indiana

Katalyst Healthcares & Life Sciences
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Responsibilities:

Product & Process Audits: Performs required audits by completing necessary inspection procedures (product operation, certification and test procedures), using the appropriate documentation, and attesting to the quality of the product prior to shipment.

Ensures and verifies accuracy and completeness of quality requirements, inspection sheets, engineering documents and sampling sheets used when inspecting parts or units.

Uses basic precision measuring tools, workmanship standards, visual inspection and referencing specifications and blueprints to identify discrepancies. May include calibration activities.

Document deficiencies identified that do not meet the specifications and requirements. Provide a means to track and address repetitive issues.

Troubleshoots daily issues and determines the root cause of the problem. Initiates proper Problem Solving: procedures in order to resolve the problem. Involves the appropriate departments.

Assist Manufacturing and Design Engineering during pilot runs of materials to determine undocumented quality requirements and/or test procedures that should be added to the Quality Requirements.

Helps maintaining the customer complaint system including necessary investigations, meetings and customer communications/visits

Supports the preparation and execution of frequent internal audits and annual surveillance/re-certification audits according to ISO 9001

Participate and make recommendations for continuous improvement activities.

Initiate Corrective/Preventative Action notices as determined necessary to ensure quality processes and products.

Provides training to the appropriate people as required on product operation and/or important information that has been identified that requires a "need-to-know status.

Continuous Improvement /Special Projects: Assist and participate when required and approved by the Quality Manager.

Requirements:

Bachelor's degree in chemistry or related discipline preferred.

Minimum 3-5 years relevant Quality experience in a manufacturing environment

Prefer experience in the automotive or plastic manufacturing industries

Familiar with plastics and engineering polymers

Ability to effectively use quality tools and techniques to determine compliance to specifications, trends, capabilities, and opportunities for continuous improvement; and the ability to demonstrate effective use of precision measuring tools and/or equipment.

Strong computer skills with Microsoft Office (especially Excel, ACCESS, PowerPoint), CRM, ERP systems

Knowledge of SPC and problem-solving tools

ISO 9001:2015: Minimum of Internal Auditor certification

Excellent organization, communication, planning, telephone, and interpersonal skills

Ability to present to all levels of an organization.

Able to work as a team member with a wide variety of people.

Able to work under stress and solve problems quickly.

Preferred: Six sigma green/black belt and LEAN experience

Date Posted: 01 May 2024
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