Sr. Software Quality Engineer; Computer Software Validation-CSV

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.

• 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).

• 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.