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Sr. Software Quality Engineer (Computer Software Validation-CSV) Job Opening In Jacksonville Florida – Now Hiring Macpower Digital Assets Edge Private Limited


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.




Required Skill Profession

Other General


  • Job Details

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