Quality Engineer – Contract (Lafayette, IN)
Stark Pharma · Lafayette
Job description
About the role
We are looking for a Quality Engineer to support manufacturing quality and process improvement initiatives in a highly regulated environment. The role will focus on quality systems, APQP activities, risk mitigation, 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.
- Execute APQP activities and risk mitigation processes using tools such as Process Flow Diagrams, PFMEA, and Control Plans.
- 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 profile
- Bachelor’s degree in Engineering from an ABET‑accredited program.
- Minimum 2 years of experience in quality engineering or related manufacturing roles.
- Strong understanding of manufacturing quality systems and process improvement methodologies.
Required skills
- APQP
- PFMEA
- Control Plans
- Root Cause Analysis
- Process Flow Diagrams (PFD)
- Inspection Plans
- Quality Systems
- Data Analysis and benchmarking
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Stark Pharma
Lafayette