Indotronix Avani Group · 7 hours ago
Quality Assurance Specialist
Indotronix Avani Group is seeking a Quality Assurance Specialist to develop and implement a compliant and cost-effective quality system. The role focuses on ensuring that products and services are reliable, safe, and effective, specifically within the Medical Device, Life Sciences, or Healthcare industry.
Responsibilities
Responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective
Understand the importance of quality compliance with medical device industry data
Qualification
Required
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)
Usage of Power Point, Excel, Word
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills
Preferred
Bachelor's degree in Engineering, Computer Science, Heath Science
Experience with ETQ Quality Management System
Experience in TrackWise QMS a plus
Needs to be a quick learner. Used to working in a tight deadline environment. Highly organized
Company
Indotronix Avani Group
Indotronix Avani Group is a consultancy that offers machine learning, cloud computing, software development and SaaS services.
Funding
Current Stage
Late StageRecent News
2023-12-25
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