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

Macpower Digital Assets Edge Private Limited
  • Jacksonville, FL
  • $45 Per Hour
  • Quick Apply
1 day ago

Job Description

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:
  • 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.
  • Medical device process validation experience (preferred).
  • Experience in Quality Auditing and notified body inspections (preferred).
  • Background in Quality Systems process development, support, integration, or enhancement (preferred).
  • Experience in training or coaching others (preferred).
  • Certification as a Software Quality Engineer (CSQE) or Quality Engineer (CQE) (preferred).
Must-Have Skills:
  • 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.

Numbers & Facts

LocationJacksonville, FL
Salary$45 Per Hour

Skills

  • Assembly Lineunmatched
  • Auditingunmatched
  • Certified Quality Engineer (CQE)unmatched
  • Change Controlunmatched
  • Change Managementunmatched
  • Coachingunmatched
  • Code Reviewsunmatched
  • Computer Softwareunmatched
  • Cross-Functionalunmatched
  • Data Qualityunmatched
  • Documentationunmatched
  • Establish Prioritiesunmatched
  • External Auditunmatched
  • FDA (Food and Drug Administration)unmatched
  • ISO (International Organization for Standardization)unmatched
  • Internal Auditunmatched
  • Manufacturingunmatched
  • Manufacturing Execution Systems (MES)unmatched
  • Manufacturing Operationsunmatched
  • Medical Equipmentunmatched
  • Policy Implementationunmatched
  • Process Developmentunmatched
  • Process Improvementunmatched
  • Process Validationunmatched
  • Production Systemsunmatched
  • Project Planningunmatched
  • Quality Assuranceunmatched
  • Quality Engineeringunmatched
  • Quality System Requirements (QSR)unmatched
  • Regulationsunmatched
  • Requirements Managementunmatched
  • Requirements Validation/Verificationunmatched
  • Sales Qualificationunmatched
  • Software Designunmatched
  • Software Development Lifecycle (SDLC)unmatched
  • Software Engineeringunmatched
  • Software Specificationunmatched
  • Software Testingunmatched
  • Software Validationunmatched
  • Supervisory Control and Data Acquisition (SCADA)unmatched
  • System Validationunmatched
  • Systems Maintenanceunmatched
  • Technical Writingunmatched
  • Test Scriptsunmatched
  • Traceabilityunmatched
  • Validation Documentationunmatched
  • Writing Skillsunmatched

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