MillenniumSoft Inc · 6 hours ago
Quality Engineer - Onsite (Urgent Need)
MillenniumSoft Inc is seeking a Quality Engineer to join their team in Irvine, California. The role involves evaluating and controlling product and service quality, resolving production issues, and ensuring compliance with quality standards and regulatory requirements.
Staffing & Recruiting
Responsibilities
Quality Engineering is responsible for product and service quality evaluation and control
Works cross-functionally in the development and or maintenance of products or services
The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured
Demonstrates basic knowledge of quality engineering policies, principles and best practices
Demonstrates basic knowledge of FDA/ISO requirements
Applies basic statistical sample size calculations to work for quality determination on simple projects
Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with direct supervision
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
Has basic knowledge of theories, practices and procedures in a job family or skill
Applies knowledge and skills to complete own work
Depends on others for instruction, guidance and direction
Develops competence in own area by performing routine work
Supports management review and data preparation entry and analytics for the site
Qualification
Required
Demonstrates basic knowledge of quality engineering policies, principles and best practices
Demonstrates basic knowledge of FDA/ISO requirements
Applies basic statistical sample size calculations to work for quality determination on simple projects
Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with direct supervision
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
Has basic knowledge of theories, practices and procedures in a job family or skill
Applies knowledge and skills to complete own work
Depends on others for instruction, guidance and direction
Develops competence in own area by performing routine work
Supports management review and data preparation entry and analytics for the site
Company
MillenniumSoft Inc
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H1B Sponsorship
MillenniumSoft Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (3)
2020 (3)
Funding
Current Stage
Growth StageCompany data provided by crunchbase