Senior or Lead Software Quality Engineer
3 weeks ago
Job Title: Senior or Lead Software Quality Engineer
Location: Irving TX
Duration: 12 Months Contract ( with possible extensions)
Job Description:
Position Overview:
- We are seeking a Senior or Lead Software Quality Engineer to lead and maintain software quality engineering processes and support compliance for regulated software applications across our organization. The ideal candidate will have substantial experience in software quality within a regulated environment, working with GxP systems, and will collaborate closely with cross-functional teams to assure quality, compliance, and audit readiness. This role also involves training, validation, and improvement of software development practices in line with FDA and other regulatory standards.
Key Responsibilities:
- Oversee and approve Software Lifecycle (SLC) deliverables for regulated applications, including Risk Classifications, Requirements, Config/Design Specifications, IQ/OQ/PQ, Trace Matrix, and Summary Reports.
- Collaborate with cross-functional teams to enhance compliance capabilities, ensuring deliverables align with quality standards and business needs.
- Review CAPAs, Change Controls, and Defects for GxP applications.
- Provide audit support for internal and external audits, including Part 11 and risk-related audits.
- Work with various software tools including ALM, TrackWise, JIRA, Confluence, and other integration tools to maintain compliance and software quality.
- Lead training sessions to enhance understanding and adherence to the company’s software development and validation program.
- Assist Design and Manufacturing Engineering teams with system/software requirements, verification, and validation processes.
- Manage software validation protocols, ensuring traceability to system/software requirements.
- Implement solutions for code control and oversee Code Control and Software Event/Defect Tracking systems.
- Conduct and maintain software-related risk analysis.
- Design and implement product and process improvement methodologies such as Six Sigma and Lean Manufacturing.
- Actively participate in QMS, EMS, and other regulatory-compliance initiatives.
- Maintain cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.
Qualifications:
- Education: Bachelor’s degree in Engineering or Technical Field with at least 8 years of relevant experience, or Master’s degree with at least 5 years of relevant experience.
- Experience: Minimum of 7 years in Software Quality Engineering, with a strong background in regulated industries, particularly GxP systems.
- Technical Skills: Advanced proficiency in statistical/data analysis, report writing, IT/data mining, and knowledge of FDA regulations (21 CFR Part 11, 820, Annex 11), ISO 13485, and IEEE 1012.
- Software Proficiency: Experience with Quality and Test Management Tools such as TrackWise, ComplianceWire, Veeva, ALM, and JIRA.
- Industry Knowledge: Familiarity with FDA, GMP, GAMP5, ISO 27001, and experience with SaaS, IaaS, PaaS, COTS, and custom applications.
- Audit Experience: Demonstrated experience in audit support for Data Integrity (both internal and external).
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