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Dexian · 3 days ago

Quality Engineer

Cedar Creek, TX

Full-time

Onsite

Mid Level

$35/hr - $38/hr

4+ years exp

Dexian is a leading provider of staffing, IT, and workforce solutions. The Quality Engineer role is dedicated to ensuring the highest quality experiences for patients and customers, providing engineering guidance and expertise to enhance process, data, and product quality.

ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency

H1B Sponsor Likely

Hiring Manager

Abhishek Shitole

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

Quality AssuranceRegulatory ComplianceRoot Cause AnalysisSix SigmaISO 13485FDA RegulationsAnalytical SkillsCommunication SkillsTeam Player

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 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

Company

Dexian

Glassdoor3.5

Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.

Founded in 1994

Mclean, Virginia, USA

1001-5000 employees

https://dexian.com

H1B Sponsorship

Dexian 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 (65)