Compunnel Inc. · 2 days ago
Quality Engineer
Cedar Creek, TX
Contract
Onsite
Mid, Senior Level
$35/hr - $40/hr
4+ years expCompunnel Inc. is focused on quality assurance in the life sciences sector, and they are seeking a Quality Engineer to lead quality assurance activities and initiatives. The role involves supporting audits, applying regulatory standards, and driving strategic quality assurance projects.
Information Technology & Services
Hiring Manager
Chirag Soni
Responsibilities
Drives quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and supports Product Complaints technical investigations for the relevant product platforms
Support 3rd party audit of site through audit prep and participating in the front/back room
Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities
Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments
Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic feedback
Act as an SME in quality assurance and scientific matters as applicable
Develop and drive key strategic quality assurance initiatives throughout the organization
Contributes to the development of new projects/programs/processes
Lead/drive root cause investigations for multiple issues, including complaints, NCRs, Deviations, OOS, etc
Leads projects requiring representation of the organization to internal and/or external customers or others, providing expertise and promoting solutions
Qualification
Required
Bachelor's or Master's Degree in biology, chemistry, biotechnology, engineering, or a related field required
4+ years of experience in a similar position within the Life science industry required
Familiarity with medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746 is required
Strong organizational and analytical skills with a focus on finding effective and efficient solutions in compliance with the regulations
An effective communicator at all levels, both internally and externally
Team player with the ability to make independent decisions within the framework and guidelines of the organization
Preferred
Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQE, CQA, etc., is preferred
Company
Compunnel Inc.
Compunnel Inc. is where AI-native solutions meet human ingenuity, helping enterprises reimagine talent, technology, and growth.
5001-10000 employees
H1B Sponsorship
Compunnel 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
2025 (2276)
2024 (1682)
2023 (1992)
2022 (2366)
2021 (2223)
2020 (2220)
Funding
Current Stage
Late StageLeadership Team
Andy Gaur
Founder, Chairman & CEO
Karthik Natarajan
Executive VP & CTO
Company data provided by crunchbase