Overview
Quality Engineer Jobs in Ladson, SC at Integrated Resources, Inc ( IRI )
Title: Quality Engineer
Company: Integrated Resources, Inc ( IRI )
Location: Ladson, SC
Job Details:
Title: Quality Engineer
Location: Ladson, SC
Duration: 08+ Months Contract
Key Responsibilities:
• Develop, implement, and maintain robust quality systems and procedures in line with ISO 13485, MDSAP Certifications and other industry standards.
• Perform assessments to ensure adherence and commitment to quality specifications and regulatory requirements.
SAP Quality Management (QM) Integration
• Create inspection plans in SAP
• Use the SAP QM module to manage inspections plans, record quality data, and document quality notifications.
• Ensure accurate data capture and traceability of quality-related information throughout the product lifecycle.
• Set up materials-master maintenance and complete system data correction in SAP fields and inventory locations to ensure data accuracy and warehouse optimization.
• Collaborate with IT, Planning, Supply Chain and production teams to optimize SAP processes for quality management.
Inspection and Testing
• Provide oversight for inspections and tests of raw material, components, and assist with finished product inspections using industry standard techniques.
• Review and interpret technical documents, including design specifications, engineering drawings, and regulatory standards
Risk Management & Continuous Improvement
• Assist with product quality investigations, root cause analysis and CAPA facilitation to address quality issues.
• Supports risk management activities, including risk assessments and mitigation plans in compliance with design controls.
• Supports process improvements and facilitates PDCA process for production
• Assists with Non-Conforming Material process.
Qualifications & Skills
• Demonstrates high level analytical skills to identify improvement opportunities and develop workable solutions to resolve complex problems
• Strong attention to detail and the ability to work collaboratively in a cross-functional team.
• Proactive mindset with a commitment to continuous improvement.
Education & Experience Education:
Bachelor’s degree in engineering, Quality Management or another related technical field.
Experience:
3+ years of experience in a quality engineering role or an equivalent level of knowledge in medical devices.
Proven hands-on experience with SAP, particularly the quality management module.
