LanceSoft, Inc. · 23 hours ago
Process Validation Quality Assurance Engineer (Expert Level)
Hebron, KY
Contract
Onsite
Senior Level
$47/hr - $47/hr
5+ years expLanceSoft, Inc. is seeking a Process Validation Quality Assurance Engineer to be part of the Process Validation Group, specializing in validation deliverables. The role involves collaboration with senior QA staff and responsibility for Process Validation Reagents within Reagent manufacturing.
Information Technology
Responsibilities
Write and conduct IOQ and spreadsheet validations
Complete PQ, TMV, AQ validations
Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards
Qualification
Required
Bachelor's degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area)
5+ years of experience in the medical device industry
Familiarity with CFR 21 Part 820 and ISO13485
Proficiency in Microsoft Excel
Good working knowledge of computer programming and systems
Preferred
Knowledge of PQ, TMV, AQ, NPSV validations
Exposure to Gamp5 or similar regulations
ASQ Certified Quality Engineer (CQE)
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