Aequor Information Technologies Pvt. Ltd. · 5 hours ago
Quality Engineer
Irvine, CA
Contract
Onsite
Entry Level
2+ years expAequor Information Technologies Pvt. Ltd. is seeking a Quality Engineer I to maintain quality and control of manufacturing processes and post-market performance of medical devices. The role involves collaborating with stakeholders, leading investigations, and ensuring compliance with quality standards.
ConsultingDigital MarketingInformation Technology
Hiring Manager
Prince Kumar
Responsibilities
Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance
Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks
Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
Proficient in project management, data analysis, root cause analysis, communication, and risk determination
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices
Qualification
Required
Bachelor's degree in Engineering
2 years of relevant experience in a regulated industry (FDA environment preferred)
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
Company
Aequor Information Technologies Pvt. Ltd.
Aequor information technologies (P) limited is a part of US based IT MNC having more than 10 locations around the world with $ 100 M turnover.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase