Software Quality Assurance Specialist
1 day ago
We are seeking a skilled Software Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our software solutions.
Key Responsibilities:
- Review and approve software lifecycle (SLC) deliverables for regulated applications.
- Collaborate with cross-functional teams to build compliance capabilities and ensure business needs are met.
- Review CAPAs, Change Controls, and Defects for GxP applications.
- Work with global teams and provide audit support.
- Utilize various applications and tools, including ALM, TrackWise, JIRA, Confluence, and integration tools.
Qualifications:
- Bachelor's degree with 8+ years of experience or Master's degree with 5+ years of experience.
- Prior experience in the regulated industry, specifically GxP systems.
- Strong knowledge of FDA regulations (21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485, ISO 27001).
- Proficiency in Quality Management Tools and Test Management Tools (TrackWise/ComplianceWire/Veeva, ALM, JIRA, etc.).
- Expertise in data integrity and prior audit support experience.
- Experience working with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Commercial-off-the-Shelf (COTS), and custom applications.
Benefits:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and supportive work environment.
- Medical, Vision, and Dental Insurance Plans.
- 401k Retirement Fund.
About the Company:
We are a leading healthcare company dedicated to improving lives worldwide. Our diverse portfolio includes medical devices, diagnostics, nutrition products, and branded generics. We are committed to developing groundbreaking technologies that address critical healthcare challenges and empower people to live healthier lives.
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