Indotronix Avani Group · 18 hours ago
Quality Complaints Specialist
Irvine, CA
Contract
Onsite
Mid LevelIndotronix Avani Group is seeking a Quality Complaints Specialist responsible for developing and implementing a quality system for reliable and safe products and services. The role requires expertise in data analysis and compliance with FDA regulations in the medical device industry.
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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 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)
Preferred experience with ETQ Quality Management System
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
Qualification
Required
Responsible for developing and implementing a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective
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)
Preferred
Preferred experience with ETQ Quality Management System
Experience in Track wise QMS a plus
Company
Indotronix Avani Group
The Indotronix Avani Group is an award-winning staffing, consulting, and technology solutions company with a footprint across the United States, Canada, and India.
Founded in 2016
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mitch Meller
Chief Operating Officer
Recent News
2023-12-25
Company data provided by crunchbase