LanceSoft, Inc. ยท 1 day ago
Quality Engineer
Cedar Creek, TX
Full-time, Contract
Onsite
Mid Level
$34/hr - $37.88/hr
4+ years expLanceSoft, Inc. is a premier laboratory partner providing life science, diagnostic, and applied market laboratories worldwide. The Quality Engineer role is dedicated to ensuring the highest quality experiences for patients and customers by leading process and product improvements and providing specialized quality-related services across various departments.
Information Technology
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, or equivalent experience
4+ years of experience in a similar position within the Life science industry
Familiarity with medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746
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
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
5001-10000 employees
H1B Sponsorship
LanceSoft, 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 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase