Quality Engineer

Stark Pharma Solutions Inc

Lafayette, IN

JOB DETAILS
SKILLS
ABET (Accreditation Board for Engineering and Technology), Advanced Product Quality Planning (APQP), Analysis Skills, Benchmarking, Bill of Materials (BOM), Communication Skills, Continuous Improvement, Corrective Action, Cross-Functional, Data Analysis, Documentation, Engineering Drawing, Manufacturing, Manufacturing Systems, Manufacturing/Industrial Processes, Metrics, Operations Processes, Organizational Skills, Process Capability, Process Failure Mode and Effects Analysis (PFMEA), Process Flow Diagram (PFD), Process Improvement, Product Design, Product Reviews, Production Support, Quality Assurance, Quality Engineering, Quality Management, Regulatory Compliance, Risk Management, Root Cause Analysis, Systems Maintenance
LOCATION
Lafayette, IN
POSTED
5 days ago

Job Title: Quality Engineer

Location: Lafayette, IN

Duration: 6 12 Month Contract

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.

The ideal candidate will have experience in manufacturing quality engineering, root cause analysis, APQP methodologies, and production quality support.

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
  • Track quality improvement recommendations through implementation and effectiveness verification
  • 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

About the Company

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Stark Pharma Solutions Inc