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