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

Computer Software Validation LeadResponsibilities: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.