Analista De Qualidade Sênior | São Paulo

Roche

São Paulo, Brazil
Quality management system (qms)
Capa and deviation management
Supplier qualification and monitoring
Develop, review, and implement policies, procedures (SOPs) and work instructions, ensuring QMS compliance with corporate guidelines and current regulations

Job Summary

  • Develop, review, and implement policies, procedures (SOPs) and work instructions, ensuring QMS compliance with corporate guidelines and current regulations.
  • Plan, conduct, and monitor internal, external, and distributor audits, reporting results and ensuring effective implementation of action plans.
  • Structure and analyze performance indicators (KPIs) and quality goals, using data for management reports and decision support.

Matching Summary

Develop, review, and implement policies, procedures (SOPs) and work instructions, ensuring QMS compliance with corporate guidelines and current regulations.

Skills & Requirements

Must-have

  • Quality Management System (QMS)
  • CAPA and deviation management
  • Supplier qualification and monitoring
  • Internal and external audits
  • Lean, Six Sigma, Scrum methodologies

Nice-to-have

  • Lean mindset for process improvement
  • Digital mindset with AI tools
  • Assertive communication and influence
  • Systemic vision of the business

Key Requirements

  • 5+ years in Quality in Healthcare/Pharma/Diagnostics
  • Advanced English proficiency
  • ISO 13485 and ISO 14971 knowledge
  • Experience in audits (audited/auditor)

Work Rights

Not specified

Tailored Resume

Cover Letter