Quality Engineer

Overview

Quest Medical, Inc., Allen, Texas, United States of America

Posted Monday, November 4, 2024 at 6:00 AM

As a part of the team, you will be contributing to each of our core beliefs:
Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.

Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.

Responsible for maintaining and improving the quality management system. Performs activities to support quality aspects of design and development, manufacture, and post-production of components and finished products. Conducts Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implements corrective actions to eliminate quality problems. Leads teams focused on CAPA. Leads Risk Assessment activities related to new and existing products.

Supports supplier quality program by performing audits, managing supplier metrics, and managing supplier corrective action plans. Develops various product tests and conducts data analysis. Manages engineering projects. Supports the internal and external audit program. Uses statistical tools to analyze data, make acceptance decisions, and improve process capability.

• Support daily manufacturing activities and work with Engineers to resolve line issues and implement corrective actions. Product areas include embedded software devices, electronics and electro mechanical components.
• Hands-on experience in developing Quality Systems, Processes and Procedures.
• Experience in Product Lifecycle Management and Product Data Management.
• Demonstrated capability in Quality Concepts, Quality Tools, Statistical Analysis and Metrics reporting.
• Provide technical support for incoming inspection and lot release testing activities.
• Analyze Product Structure, Product Data and manufacturing transfer readiness. Initiate and implement improvement actions for product and process quality improvements.
• Provide support and leadership to Product Improvement Teams as lead Quality Engineer.
• Lead defect and repair reduction programs to drive down Cost of Quality (COQ) metrics. Conduct internal and external audits for improving performance and quality metrics.
• Manage customer complaint and NCMR 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 engineering projects focused on improving product quality and QMS compliance.
• Generate, review and approve ECOs and Validation Reports.
• Provide oversight 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. Review and approve all studies, qualifications, and engineering change orders associated with the project.
• Develop and revise quality system procedures (SOPs and WIs).
• Develop/ 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.
• Provide expertise in statistical analyses and interpretations for investigations, specification-setting activities, and test protocols.
• Participate in audits with FDA, ISO, MDD, and other regulatory agencies.
• Lead major quality projects that result in CPAR files.
• Use effective problem solving techniques to support successful completion of job duties.
• Strive to constantly innovate and implement improvements for improved methods for testing components.
• Work independently without supervision and have the ability to mentor junior quality associates.

• Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience.
• A minimum of 10 years of experience in a quality engineering role in regulated industry experience such as medical…