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KEKetryx

QA/RA Lead(m/w/x)

Wien
from 90,000 / year
Full-timeWith Home OfficeExperienced
AI/ML
Apply now

QMS setup and deployment for medical software clients, consulting on ISO 13485 and EU MDR. 4-8 years in quality systems management for medical software required. Generous stock options.

Requirements

  • 4-8 years experience in quality systems management, management representative or senior specialist role
  • Familiarity with eQMS implementation, validation
  • Deep expertise in QMS setup, sub-systems, implementation
  • Strong knowledge of ISO 13485 and Global QMS
  • Expertise in AI, Digital, SaMD, Cyber Compliance (SOC 2, ISO 27001)
  • Deep understanding of medical device cybersecurity
  • Experience as QMS representative in regulated environments
  • Proven experience managing audit lifecycles
  • Familiarity with continuous validation methodologies (CSV, GAMP 5, ISO 13485) and documentation
  • Experience with regulatory and Notified Body submission
  • Background in medical device industry quality systems
  • Ability to work independently and own complex regulatory projects
  • Proven track record in consulting or client-facing roles
  • Experience at large medical device companies
  • Background with consulting firms specializing in QMS setup
  • Startup experience (Series A/B) with QMS implementation
  • Specializations in cybersecurity, usability, or computer software validation
  • Experience scaling quality operations in high-growth environments
  • Knowledge of AI applications in regulatory affairs
  • Submission experience

Tasks

  • Lead QMS setup and deployment for medical device clients
  • Own and manage QMS templates and compliance frameworks
  • Consult on ISO 13485, EU MDR/IVDR, UKCA, GxP
  • Scale operations for high-growth clients
  • Develop repeatable QMS deployment processes
  • Leverage AI for automatic compliance
  • Drive and support internal and external audit programs
  • Manage customer audits
  • Oversee regulatory inspections
  • Orchestrate continuous validation lifecycle
  • Draft, review, and approve documentation
  • Ensure real-time compliance program management
  • Shape regulatory affairs through innovative product development
  • Work independently on complex QA projects
  • Ensure customer success throughout engagement lifecycle

Work Experience

  • 4 - 8 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • English – Business Fluent

Tools & Technologies

  • eQMS
  • ISO 13485
  • AI
  • Digital
  • SaMD
  • SOC 2
  • ISO 27001
  • CSV
  • GAMP 5

Benefits

Bonuses & Incentives

  • Performance-based bonus

Competitive Pay

  • Equity options
  • Competitive compensation
  • Generous stock options

Flexible Working

  • WFH option

More Vacation Days

  • Generous PTO for full-time
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ketryx and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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