Indotronix Avani Group · 1 day ago
Quality Assurance Engineer
Irvine, CA
Contract
Onsite
Entry, Mid Level
$78/hr - $78/hr
2+ years expIndotronix Avani Group is seeking a Quality Assurance Engineer specializing in Medical Devices. The role involves developing and implementing a quality system to ensure product reliability and compliance with industry regulations.
ConsultingMachine LearningSoftware
Hiring Manager
Chandra Shekar Kandala
Responsibilities
Responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective
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 with medical device industry data
Knowledge of applicable FDA regulations for medical device industry (CFR, ISO standards)
Experience in Track wise QMS a plus
Needs to be a quick learner. Used to working in a tight deadline environment. Highly organized
Usage of Power Point, Excel, Word
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills
Strict attention to detail
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 of 2 years' experience in 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 with medical device industry data
Knowledge of applicable FDA regulations for medical device industry (CFR, ISO standards)
Needs to be a quick learner. Used to working in a tight deadline environment. Highly organized
Usage of Power Point, Excel, Word
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills
Strict attention to detail
Preferred
Bachelor's degree in Engineering, Computer Science, Heath Science
Experience with ETQ Quality Management System
Experience in Track wise QMS 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