Project Quality Engineer

Job Description

What are my responsibilities?

RAQA (Regulatory Affairs Quality Assurance) professional is responsible for implementation of process across the assigned projects,

  • Process facilitation to project teams from Initiation till Release of the project
  • Conduct audit to identify process gaps in the project
  • Review the project deliverables and provide feedback to project teams
  • Improve process awareness amongst employees by conducting training programs
  • Define relevant project metrics and Perform statistical analysis on metrics data collated
  • Conduct Lessons Learned session
  • Regulatory related documents to be maintained in the centralized tool

What do I need to qualify for this job?

  • Education: BE / B.Tech / MCA / ME / M.Tech/ Graduate from a recognized university
  • 3-7 yrs of experience in Software Quality Assurance / Medical Devices / Regulatory

Desired Skill Set:

  • Experience in implementation of Design Controls across projects
  • Knowledge on various software development life cycle methodologies
  • Good knowledge of ISO 13485, 14971, 21 CFR Part 820, IEC 62304
  • Proficient in using Microsoft office
  • Strong presentation skills and ability to interact with Business Partners
  • Excellent interpersonal skills and ability to work independently
  • Strong written and oral communication skills

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Experienced Professional

Job Type: Full-time

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