What are the responsibilities and job description for the Quality Engineer position at Stark Pharma?
Hi,
My name is Karthik Mutyala and I m a Recruitment Manager with Stark Pharma, specializing in pharmaceutical, biotechnology, and medical device roles. I came across your profile and wanted to see if you are open to new opportunities.
If interested, please send me your updated resume along with the best number and time to reach you.
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
My name is Karthik Mutyala and I m a Recruitment Manager with Stark Pharma, specializing in pharmaceutical, biotechnology, and medical device roles. I came across your profile and wanted to see if you are open to new opportunities.
If interested, please send me your updated resume along with the best number and time to reach you.
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
- 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