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Added 12 mins ago
Cyber - AI Engineer - Manager - Consulting
EY
Phoenix, AZ · Tucson, AZ
As a Cyber AI Engineer, you will work with client security and engineering teams to deploy AI workflows for threat investigation, detection engineering, vulnerability analysis, and…
Added 13 mins ago
Java Software Engineer - Mid Level
USAA
Phoenix, AZ
As a dedicated Java Software Engineer - Mid Level, you will join a dynamic, startup-minded team within the Investment Experience Technology organization at USAA, part of the Technology…
Added 13 mins ago
Senior Test Engineer
Kelly Services
Phoenix, AZ
A growing communications technology organization is seeking a Senior Test Engineer to join its team in the Phoenix-area on a full-time basis. This onsite role focuses on testing and…
Added 13 mins ago
EG
Quality Assurance Engineer - PHP
Eliassen Group
Phoenix, AZ
- $40 to $50 USD / hour
Our client seeks a results-driven Senior Quality Assurance Engineer to support Policyholder Portal applications. The role requires manual, automation, mobile, API, and database testing…
Added 17 mins ago
DS
(1116127) Energy Electronics Software Engineer
Diversified Services Network, Inc.
Peoria, IL
- $94,000 to $100,000 USD / year
The Energy Electronics Software Engineer focuses on software-in-the-loop testing and automation for embedded electronic control systems supporting diesel engine programs. This position is…
Added 49 mins ago
Z
Software Quality Engineer
ZipLiens
Franklin, TN
- $77,000 to $104,000 USD / year
Zipliens is looking for a Quality Engineer to join our team and own quality for a product area within the applications we build for the legal industry. After several years of high growth,…
Added 49 mins ago
Associate Director, Power Systems Engineering
Scout Clean Energy
Boulder, CO
o Power Systems Engineer (BESS & Power Conversion Systems)
Added 49 mins ago
QA Test Engineer
TA
NY · New York, NY
We are looking for a QA Test Engineer to join our quality team and help us ship reliable software. In this role you will design and run test plans, write and maintain automated tests for…
Added 50 mins ago
Forward Deployed Engineer
Newcode.ai
Chicago, IL
At least three years in a technical, client-facing role, for example solutions engineer, implementation consultant, technical consultant, automation specialist, or developer.
Added 50 mins ago
DS
(1119604) Lead Software Engineer - Emerging Technologies
Diversified Services Network, Inc.
Chicago, IL
- $140,000 to $145,000 USD / year
Diversified Services Network, Inc. (DSN) is seeking a full-time Lead Software Engineer – Emerging Technologies to join our team in your choice of our Chicago, IL; Peoria, IL; Irving, TX; or…
Added 50 mins ago
DS
(1119604) Lead Software Engineer - Emerging Technologies
Diversified Services Network, Inc.
Peoria, IL
- $140,000 to $145,000 USD / year
Diversified Services Network, Inc. (DSN) is seeking a full-time Lead Software Engineer – Emerging Technologies to join our team in your choice of our Chicago, IL; Peoria, IL; Irving, TX; or…
Added 50 mins ago
DS
(1119604) Lead Software Engineer - Emerging Technologies
Diversified Services Network, Inc.
Irving, TX
- $140,000 to $145,000 USD / year
Diversified Services Network, Inc. (DSN) is seeking a full-time Lead Software Engineer – Emerging Technologies to join our team in your choice of our Chicago, IL; Peoria, IL; Irving, TX; or…
Added 50 mins ago
DS
(1119604) Lead Software Engineer - Emerging Technologies
Diversified Services Network, Inc.
Broomfield, CO
- $140,000 to $145,000 USD / year
Diversified Services Network, Inc. (DSN) is seeking a full-time Lead Software Engineer – Emerging Technologies to join our team in your choice of our Chicago, IL; Peoria, IL; Irving, TX; or…
Added 51 mins ago
PP
QA Automation Engineer
Pecan POS
Remote, United States
- $90,000 to $111,000 USD / year
As a QA Automation Engineer, you will help ensure high product quality across our web and API systems by building scalable automated test coverage and continuously improving our testing…
Added 51 mins ago
P
QA Engineer
Purple-Squirrels
Newark, CA
- $110,000 to $135,000 USD / year
Own end-to-end QA for assigned feature areas - test planning, test-case design, exploratory testing, and regression coverage, not just automation
Added 56 mins ago
AR
Mid/Senior Level Robotics Software Engineer
AlphaOne Robotics
Dallas, TX
- $100,000 to $150,000 USD / year
Join our innovative robotics team as a Robotics Software Engineer, where you'll play a pivotal role in building foundational technologies for a disruptive company transforming warehouse…
Added 56 mins ago
AR
Junior Robotics Software Engineer
AlphaOne Robotics
Dallas, TX
- $60,000 to $90,000 USD / year
Join our innovative robotics team as an Junior Robotics Software Engineer, where you'll play a key role in supporting the foundational technologies for a disruptive company transforming…
Added 58 mins ago
E
Founding Product Engineer
Emerge
New York City, NY
- $120,000 to $200,000 USD / year
Emerge Career’s mission is to break the cycle of poverty and incarceration. We’re not just building software; we’re creating pathways to real second chances. Through an all-in-one platform…
Added 1 hour ago
Founding Motion Planning & Prediction Engineer
Greenlight Robotics
San Francisco, CA
Deploy & Field Test: Deploy and field test new software on our prototype vehicle and customer vehicles.
Added 1 hour ago
NC
Junior Software Engineer (QA & Automation)
Ngo Consulting Partners
Remote, United States
- $28 to $38 USD / hour
This role is ideal for an early-career engineer excited to work on AI and data-driven products. You’ll help ensure the accuracy, consistency, and reliability of our systems while learning…
Added 1 hour ago
SA
Electrical Engineer - Subsea Motion Control & Power Electronics
Straffing AI
San Diego, CA
- $125,000 to $150,000 USD / year
We are seeking an experienced Electrical Engineer to join an innovative engineering team developing advanced electromechanical systems for demanding subsea applications. This is an…
Added 1 hour ago
AM
Software Engineer, AI & Automation
Ace Marketing Services, Inc.
Winter Park, FL
- $55 to $65 USD / hour
Software Engineer, AI & Automation - Ace Marketing Services
Added 1 hour ago
M
Senior Software Engineer
Microsoft
WA · Redmond, WA · Redmond
- $119,800 to $261,000 USD / year
We are seeking a highly skilled and committed Senior Software Engineer to join our team. This role is central to advancing our quantum software roadmap and requires passion for software…
Added 1 hour ago
M
Senior Software Engineer
Microsoft
WA · CA · Redmond, WA · Mountain View, CA · Redmond · Mountain View
- $119,800 to $261,000 USD / year
We are looking for a Senior Software Engineer to build the telemetry and observability foundation behind business applications and emerging agent workloads. This is a hands-on software…
Added 1 hour ago
EG
Quality Assurance Engineer - PHP
Eliassen Group
Augusta, ME
- $40 to $50 USD / hour
Our client seeks a results-driven Senior Quality Assurance Engineer to support Policyholder Portal applications. The role requires manual, automation, mobile, API, and database testing…

Katalyst Healthcares & Life Sciences

Validation Engineer/CSV Engineer

Walnut Creek, CA, United States

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Job details

Experience: Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
Posting language: English
Posted: Jul 28, 2025

Original job description

Company Description

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Responsibilities:

Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
Creation and review of validation deliverables including but not limited to Requirement Specifications (User, Functional Plan.)
Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
Traceability Matrix.
Periodic Reviews.
System Retirement/Decommissioning.
Execution of Dry/Test protocol run.
Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
Perform System Retirement/Decommissioning of systems not in business.
Work closely with software development and IT teams to establish best practices for quality and compliance.
Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.

Requirements:

A Minimum bachelor's degree in engineering, Science or related technical field.
Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
Experience with non-product software validation, including tools for development, testing, and maintenance.
Good knowledge and experience of CSV activities but not limited to.
GxP and 21 CFR Part 11 applicability/criticality assessment.
Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
Execution of Dry/Test protocols.
Conduct Periodic Reviews of systems.
Perform System Retirement of systems that are not in business.
Understanding of Medical Device Quality and Compliance.
Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
Working experience in Product Lifecycle Management (PLM) tool.
Sound knowledge of computer system development lifecycles.
Knowledge of JIRA, JAMA software and test automation is a plus.

Additional Information All your information will be kept confidential according to EEO guidelines.

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More about this job

Skills

Quality assurance methodologies
Inspection
Documentation
Software development
Regulatory compliance
Process improvement
Quality assurance procedures
Quality assurance
PLM
Atlassian JIRA
Test automation

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