Sr. Software Quality Engineer (Computer Software Validation-CSV) - MDA Edge : Job Details

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

1 month ago Be among the first 25 applicants

This range is provided by MDA Edge. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$45.00/hr - $45.00/hr

Responsibilities:

• Lead Computer Software Validation (CSV) project planning activities, including creating and updating 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 teams, sites, and operating companies in CSV.
• Identify and resolve obstacles impacting 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 audits related to CSV.
• Act as the Subject Matter Expert (SME) for CSV, leading investigations, responses, and remediation of CSV audit findings.

Qualifications:

• Strong knowledge of FDA and European medical device regulations (QSR and ISO).
• Expertise in software validation requirements for medical device production and Quality System software.
• Proficiency in GAMP5 and SDLC methodologies.
• 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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Other

Industries

• IT Services and IT Consulting

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