Jobs · Quality Assurance · Indiana

Quality Engineer

Stark Pharma Solutions Inc · Lafayette, IN · 1 mo ago
On-siteQuality AssuranceContract

Job Summary

We are seeking a Quality Engineer to support manufacturing quality and process improvement initiatives within a highly regulated manufacturing environment. This role will focus on quality systems, APQP activities, risk mitigation, process improvement, and cross-functional collaboration to ensure product quality and operational excellence.

Key Responsibilities

  • Develop, document, and maintain quality systems, procedures, and operating standards
  • Support manufacturing process improvements and quality enhancement initiatives
  • Participate in design and product reviews to ensure quality, reliability, manufacturability, and compliance requirements are achieved
  • Execute APQP activities and risk mitigation processes utilizing tools such as: Process Flow Diagrams (PFD), PFMEA, Control Plans (CP)
  • Conduct root cause analysis and implement corrective and preventive actions
  • Collaborate with cross-functional stakeholders to identify and mitigate manufacturing and process risks
  • Analyze quality data, benchmarking results, and process capability metrics to drive continuous improvement
  • Create and maintain inspection plans and inspection accountability systems
  • Review production and engineering documentation including drawings, qualification reports, assembly instructions, and BOMs

Required Qualifications

  • Bachelor's degree in Engineering from an ABET-accredited program
  • 2+ years of Quality Engineering or related manufacturing experience
  • Strong understanding of manufacturing quality systems and process improvement methodologies
  • Experience with APQP, PFMEA, Control Plans, and Root Cause Analysis
  • Strong analytical, organizational, and communication skills

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