Overview
Quality Engineer Jobs in Dallas, Texas, USA at Nordson Corporation
Position: Quality Engineer I
Job Responsibilities:
Support daily manufacturing activities and work with Engineers to resolve line issues and implement corrective actions.
Provide technical support for incoming inspection and lot release testing activities.
Provide support and leadership to Product Improvement Teams as Quality Engineer.
Manage customer complaint investigations from initiation through investigation and closure. Ensure reportability assessments are made in a timely manner for each complaint. Ensure quality, in-depth investigations are performed, including effective root cause and corrective action assessments.
Manage NCMR investigations from initiation through investigation and closure. Perform product dispositions in a timely manner. Ensure quality, in-depth investigations are performed, focusing on elimination of the defect condition through effective root cause and corrective action problem-solving techniques.
Provide input to the Supplier Quality program by evaluating potential suppliers, managing supplier corrective actions, performing supplier audits, and evaluating quality metrics.
Support the Internal Audit program by auditing, identifying and correcting deficiencies, creating reports, and conducting verifying effectiveness of corrective actions.
Provide quality engineering support to engineering project teams associated with new product development projects or process improvement projects.
Revise quality system procedures (SOPs and WIs).
Write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, test method validations, and Gage R&R studies.
Develop and maintain risk management files and quality control plans for components, devices, and processes.
Provide training and/or technical guidance to QA Technicians and production staff as required.
Use statistical analyses and interpretations for investigations, specification setting activities, and test protocols.
Participate in inspections with FDA, ISO, MDD, MDSAP, and other regulatory agencies.
Support major quality projects which result in CPAR files.
Qualifications:
Bachelor of Science degree in a technical area such as science, engineering, math, or equivalent experience.
A minimum of 2 years of experience in a quality role in a regulated industry such as medical device or pharmaceutical is preferred.
Familiarity with FDA Quality System Regulation, MDD, ISO 9001, ISO 13485, and ISO 14971 is preferred.
Strong unbiased advocate of compliance.
Ability to work efficiently in a team environment.
Must possess technical writing, project management, and fundamental problem-solving skills.
Experience using word processing, spreadsheet, data management, and/or design of experiments software programs. Familiarity with Minitab statistical software preferred.
Prior experience in auditing is desired.
Previous experience performing laboratory and/or mechanical testing required.
Excellent strong verbal and written communication skills.
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Title: Quality Engineer
Company: Nordson Corporation
Location: Dallas, Texas, USA
Category: Quality Assurance – QA/QC (Quality Engineering), Engineering (Quality Engineering)
