Indotronix Avani Group · 1 day ago
Quality Assurance Engineer (Post-Market Surveillance/Complaint)
Irvine, CA
Contract
Onsite
Entry, Mid Level
2+ years expIndotronix Avani Group is seeking a Quality Assurance Engineer to develop and implement a compliant quality system for their products and services. The role focuses on ensuring reliability, safety, and effectiveness in the medical device industry.
ConsultingMachine LearningSoftware
Responsibilities
Responsible for developing and implementing a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective
Experience in the post-market surveillance area (review of data and relationship to complaints)
Understand the importance of quality compliance in the medical device industry, based on medical device industry data
Qualification
Required
Responsible for developing and implementing a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective
Minimum 2 years of experience in the Medical Device, Life Sciences, or Healthcare industry
Expertise in extracting, filtering, validating, and downloading data from Power BI
Expertise in manipulating, and analyzing large datasets using advanced Excel functions and formulas (VLOOKUP, pivot tables, conditional formulas)
Experience in the post-market surveillance area (review of data and relationship to complaints)
Understand the importance of quality compliance in the medical device industry, based on medical device industry data
Knowledge of applicable FDA regulations for medical device industry (CFR, ISO standards)
Preferred
Bachelor's degree in Engineering, Computer Science, or Health Science
Preferred experience with the ETQ Quality Management System
Experience in Trackwise QMS is a plus
Company
Indotronix Avani Group
Indotronix Avani Group is a consultancy that offers machine learning, cloud computing, software development and SaaS services.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mitch Meller
Chief Operating Officer
Recent News
2023-12-25
Company data provided by crunchbase