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Medical Device Software Test Jobs in Florida (NOW HIRING)

System One

Test Engineer

Weston, FL · On-site

$40 - $46.66/hr

Job Title: Test Engineer Location: Weston, Florida Type: Contract Compensation: $40-46.66/hr ... Knowledge of regulatory standards applicable to medical device and software development life cycle ...

Tandemdiabetes

Knowledge of medical device software development processes, including mobile, embedded, and web ... test (excluding marijuana) and background check, which includes a review of criminal history ...

Actalent

Test Engineer

Miami, FL · On-site

Prior medical device technical support experience, including troubleshooting and field or internal ... Experience using SolidWorks or other CAD software for fixture design, jigs, or tooling. * Hands-on ...

Avani Technology Solutions, Inc.

Mobile SDET

Orlando, FL · On-site

$46.75 - $60.25/hr

M obile SDET Walt Disney Parks And Resorts U.S., Inc. 6 Months+ 1) Mobile SDET experience ... device cloud, etc.) Technical Environment java, php, angular, selenium, appium, api

Exactech

Intern - Eng Test Lab

Gainesville, FL

$15.25 - $19.75/hr

Apply engineering acumen to evaluate impact of revisions to technical standards on medical device ... Computer aided design software * Motivated to take initiative and work effectively in teams

Advita Ortho

Intern - Eng Test Lab

Gainesville, FL · On-site

$15 - $19.50/hr

Apply engineering acumen to evaluate impact of revisions to technical standards on medical device ... Computer aided design software * Motivated to take initiative and work effectively in teams

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All JobsMedical Device Software Test JobsMedical Device Software Test Jobs in Florida

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 17 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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