Flex · 2 weeks ago
Validation Quality Engineer
Austin, TX
Full-time
Onsite
Senior Level
5+ years expFlex is a diversified manufacturing partner that helps leading brands design and deliver innovative products. They are seeking a Validation Quality Engineer responsible for ensuring compliance with validation policies and procedures in medical device manufacturing.
ElectronicsManufacturingProduct Design
Responsibilities
Provide validation oversight for equipment and facilities qualification activities, ensuring compliance and recommending corrective actions as needed
Implement and enforce validation policies and procedures for medical device manufacturing
Define qualification requirements and lead assigned validation activities to completion
Interface with customers on technical and quality issues, as well as improvement initiatives
Author and execute validation plans and protocols (IQ, OQ, TMV, PQ) and other deliverables for equipment qualification and requalification
Make independent decisions related to qualification activities
Evaluate alternative methods and procedures to meet business needs
Act as a subject matter expert during regulatory, compliance, and customer audits
Review technical problems and recommend solutions to improve and streamline quality system processes
Implement validation controls across manufacturing areas in accordance with applicable policies and procedures
Manage validation and change control activities by authoring, reviewing, and approving deliverables, including validation plans, test protocols/results, risk assessments, traceability matrices, and summary reports
Monitor validation activities to ensure adherence to regulations, protocols, and methodologies, and maintain complete documentation
Support software validation and quality engineering projects as required by business needs
Qualification
Required
Typically requires a bachelor's degree in engineering or equivalent experience and training
5+ years of experience working as a validation engineer
4+ years of experience in process and facilities validation within medical device, pharmaceutical, or biotechnology industries; strong understanding of CFR Part 820, Part 11, ISO 13485, Annex 11, ISO 9001, and GAMP standards
Working knowledge of validations for processes, facilities, and utilities and statistical analysis is must
Experience in generating, reviewing, and approving validation deliverables, statistical analysis, risk management, and change management
Preferred
Project management or software validation experience is a plus
Experience in a 24/7 operations environment strongly preferred
Company
Flex
Flex designs, manufactures, and supplies electronics products for the industrial sector.
10001+ employees
H1B Sponsorship
Flex 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 (1)
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$200MKey Investors
CienaSilver Lake
2023-11-29Post Ipo Equity
2003-03-03Post Ipo Equity· $200M
1994-03-25IPO
Leadership Team
Revathi Advaithi
Chief Executive Officer
Kevin Krumm
Chief Financial Officer
Recent News
2026-01-05
solutionsreview.com
2025-11-23
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