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Quality Engineer Software Validation Jobs (NOW HIRING)

Medline

Sr Engineer Software Validation

Redmond, OR · On-site

$101K - $152K/yr

Coordinate, Execute, and Report on validation plans for custom and off-the shelf software. * Manage ... Maintain organizational excellence, including document control, quality records, detail, and ...

Medline

Sr Engineer Software Validation

Redmond, OR · On-site

$101K - $152K/yr

Coordinate, Execute, and Report on validation plans for custom and off-the shelf software. * Manage ... Maintain organizational excellence, including document control, quality records, detail, and ...

Rfamec

Software Validation Engineer

Fort Worth, TX · On-site

$80K - $100K/yr

Software Validation Engineer The Software Validation Engineer will support the integration ... cost, quality). * Ensure that base machine software changes are delivered on time for command for ...

Rfamec

$80K - $100K/yr

Software Validation Engineer The Software Validation Engineer will support the integration ... cost, quality). * Ensure that base machine software changes are delivered on time for command for ...

Altera

Software Validation Engineer

San Jose, CA

Altera is seeking a motivated Software Validation Engineer to ensure the quality and reliability of our cutting-edge software solutions for programmable logic devices! Responsibilities: * Design ...

CREXENDO, INC

Software Validation Engineer

Tempe, AZ · On-site

Crexendo Software Validation Engineer You will be part of a team working on Crexendo's (NASDAQ ... Experience with manual testing preferred * 4-7 years in Software QA * 4-7 years experience ...

ClifyX

Software Quality Engineer

Irvine, CA · On-site

... Validation V&V procedures are followed. • Review and approve software project deliverables ... quality engineering discipline or Software department and management experience in a regulated ...

Collabera

Software Validation Engineer III

Warsaw, IN · On-site

The Software Validation Engineer will be responsible for performing validation activities as new or implemented software within the operations, quality or other functions. Strong and in-depth ...

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How much do quality engineer software validation jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for quality engineer software validation in the United States is $56.31, according to ZipRecruiter salary data. Most workers in this role earn between $41.59 and $70.43 per hour, depending on experience, location, and employer.

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Infographic showing various Quality Engineer Software Validation job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 84% Physical, 1% Hybrid, and 15% Remote job distribution, with an average salary of $117,123 per year, or $56.3 per hour.

Sr. Software Quality Engineer (Computer Software Validation-CSV)

Jacksonville, FL • On-site

MDAEdge
Custom Software Development Services • 51 - 200 employees
Learn more about MDAEdgeexternal

Full-time

Re-posted 18 days ago

Job description

Job Summary:
MDAEdge is a company focused on software quality in the medical device sector, and they are seeking a Senior Software Quality Engineer to lead Computer Software Validation (CSV) projects. The role involves managing software validation documentation, supporting compliance efforts, and promoting cross-functional collaboration within the organization.
Responsibilities:
• Lead Computer Software Validation (CSV) project planning activities, including the creation and updates of User Requirements Specifications (URS), Software Design Specifications (SDS), and Requirements Traceability Matrices (RTM).
• Develop, review, and approve software validation documentation.
• Create and execute qualification protocols, document reports, and review and approve software test scripts and code reviews.
• Evaluate and approve internal and vendor software packages and test documentation.
• Prioritize and manage all assigned projects within the software validation department.
• Implement and support policies, procedures, and processes related to CSV, Software Development Life Cycle (SDLC), and software validation for computerized systems.
• Serve as the Software Quality Engineering (SQE) representative in the Change Control Board (CCB) to facilitate change validation.
• Lead Installation Qualification (IQ) activities for manufacturing lines.
• Drive CSV improvement initiatives within the manufacturing environment.
• Promote cross-functional collaboration across different teams, sites, and operating companies in the area of CSV.
• Identify and resolve obstacles that impact business needs.
• Work closely with Franchise Quality to implement and sustain Quality System initiatives at the site level.
• Support compliance efforts by ensuring audit readiness and participating in internal and external audits related to CSV.
• Act as the Subject Matter Expert (SME) for CSV, leading investigations, responses, and remediation of site-specific CSV audit findings.
Qualifications:
Required:
• Strong working knowledge of FDA and European medical device regulations (QSR and ISO).
• Expertise in software validation requirements for both medical device production and Quality System software.
• Proficiency in GAMP5 and SDLC methodologies.
• In-depth understanding of regulations for electronic records, electronic signatures, and data integrity.
• Experience in change management with strong technical writing skills.
• Hands-on experience with SCADA and/or Manufacturing Execution Systems (MES), with a background in manufacturing/operations.
• Minimum of 4 years of experience in a regulated environment.
• 2-4 years of experience in medical device regulations.
• Strong knowledge of FDA and European medical device regulations (QSR and ISO).
• Expertise in software validation for medical device production and Quality System applications.
• Working knowledge of GAMP5 and SDLC.
• Understanding of electronic records, electronic signatures, and data integrity regulations.
• Experience with change management and technical writing.
• Hands-on experience with SCADA and/or MES in a manufacturing/operations setting.
Preferred:
• Medical device process validation experience.
• Experience in Quality Auditing and notified body inspections.
• Background in Quality Systems process development, support, integration, or enhancement.
• Experience in training or coaching others.
• Certification as a Software Quality Engineer (CSQE) or Quality Engineer (CQE).
Company:
The world doesn't have a talent shortage. It has a talent alignment problem. MDA Edge exists to fix that. Founded in , the company is headquartered in Sheridan, WY, US, , with a team of 51-200 employees. The company is currently Growth Stage.

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