What are the responsibilities and job description for the Quality Engineer position at Intellectt Inc?
Job Title: Quality Engineer
Location: Illinois (IL)
Duration: 12 Months
Employment Type: W2 Contract
Job Summar
yOur client is seeking an experienced Quality Engineer to support quality and compliance activities within a regulated medical device manufacturing environment. The ideal candidate will have hands-on experience with quality systems, investigations, nonconformances, CAPA, risk management, and continuous improvement
.
Key Responsibiliti
- esSupport quality engineering activities throughout the product and manufacturing lifecycl
- e.Lead and support investigations related to nonconformances, deviations, complaints, and CAP
- A.Perform root cause analysis and develop effective corrective and preventive action
- s.Conduct risk assessments and support process and product quality improvement
- s.Review and maintain quality documentation in compliance with FDA and ISO 13485 requirement
- s.Collaborate with Manufacturing, Engineering, Operations, and Quality teams to resolve quality issue
- s.Support audits, inspections, change controls, and continuous improvement initiative
- s.Analyze quality data and trends to identify opportunities for process improvemen
- t.Ensure compliance with applicable medical device regulations and internal quality procedure
s.
Required Qualificati
- onsBachelor's degree in Engineering, Science, or a related technical fie
- ld.3 years of Quality Engineering experience in the medical device indust
- ry.Strong knowledge of FDA regulations and ISO 134
- 85.Hands-on experience with CAPA, nonconformance investigations, root cause analysis, and risk manageme
- nt.Experience working with Quality Management Systems (QM
- S).Strong problem-solving, documentation, communication, and cross-functional collaboration skil