Quality Assurance Specialist Medical Device Posted 9 month ago

Premier Life Sciences LLC | Austin, Texas, US Full Time | Onsite

 

Job Descriptions

Medical Device/Pharma/Bio Pharma Experience is must


Responsibilities:

  • Conduct Software Quality Assurance (SQA) with a focus on reviewing and approving Software Development Life Cycle (SDLC) deliverables.
  • Previous experience in SDLC/Software Validation, including writing and executing SDLC deliverables such as MVP testing.
  • In-depth knowledge of Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Traceability Matrix, and System Release.
  • Several years of SQA experience, particularly in reviewing and approving SDLC deliverables like MVP, Risk Assessment (FMEA), IQ, OQ, PQ, Traceability Matrix, and writing System Certifications.
  • Provide SQA support for the review, approval, and implementation of regulated IT applications.
  • Collaborate with the development team to integrate compliance capabilities, ensuring the quality of deliverables meets business needs.

Qualifications:

  • Strong validation expertise with over 7 years of experience.
  • Ensure IT validation packages are inspection-ready and comply with company policies and procedures.
  • Previous experience in automated testing and implementation.
  • Proficient in understanding GxP regulations and validation principles.
  • Solid experience in reviewing CAPAs, Change Control, and Defects in relation to Software Validation.
  • Familiarity with various applications and tools such as JIRA, Confluence, Client-ALM, Tosca, Confluence, Veera, Qtest, M-Files, or other continuous integration tools.
  • Understanding of the differences between Waterfall and Agile software development methodologies.
Side Kick

AI-Powered Career Coach assists you with everything around career !

What is a super perfect resume !

7:20

The secret to super perfect resume is keep it simple don’t over do it. Do you need help to create one !

7:20