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Engineering - Engr II
2 weeks ago
Duration: 06 months
Location: 12050 Lone Peak Drive, Draper, Utah 84020
Schedule: 1st shift
Client: Edwards Lifesciences
Job ID: 13384-1
Payrate: XX45XX.
Summary:
The Quality Engineer applies engineering principles to ensure product and process compliance with internal and external quality standards. This role focuses on managing CAPA and NCR processes, performing receiving inspections, and supporting quality system activities to drive continuous improvement and regulatory compliance.
Job Responsibilities:
• CAPA Management: Lead and support Corrective and Preventive Action (CAPA) investigations, including root cause analysis, action implementation, and effectiveness verification.
• Nonconformance (NCR) Handling: Review and process NCRs, coordinate cross-functional resolution efforts, and ensure timely closure in compliance with quality procedures.
• Receiving Inspection: Perform inspections of incoming materials and components to verify conformance to specifications and regulatory requirements. Maintain inspection records and collaborate with suppliers on quality issues.
• Quality System Support: Assist in internal and external audits, maintain documentation for ISO 13485 and FDA QSR compliance, and support quality system improvements.
• Data Analysis & Reporting: Analyze quality data, prepare reports on trends and metrics, and recommend improvements to enhance product quality and process efficiency.
Skills:
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication.
• Ability to read and interpret engineering drawings, blueprints, and technical documentation.
• Proficiency in quality tools such as FMEA and root cause analysis.
• Experience with quality software systems and inspection tools.
• Team-oriented with attention to detail.
Education/Experience:
• Bachelor's degree in engineering required.
• 2-4 years experience required.
• Familiarity with CAPA, NCR, receiving inspection, and regulatory compliance standards.
