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Qa Engineering Lead

Brazil, São Paulo · Job Posted June 10, 2026
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Job Description

This is where your creativity addresses challenges! As QA Engineering Lead you provide Quality Assurance leadership and oversight for engineering-related quality processes across medical device, solutions, and pharmaceutical manufacturing sites. This role ensures that validation, change control, metrology, utilities/facilities, and operational excellence activities are executed in compliance with applicable medical device, pharmaceutical, and combination-product regulations and standards, while enabling efficient, reliable, and scalable operations. The role partners closely with Engineering, Manufacturing, Operations, IT, Regulatory Affairs, and Quality teams to ensure that technical changes, systems, and infrastructure remain compliant, well controlled, and aligned with business objectives and patient safety requirements across regulated environments.

Job Responsibility

  • Provide QA oversight and governance for validation, change control, and lifecycle management of equipment, processes, utilities, facilities, and computerized systems across medical device and pharmaceutical operations, ensuring compliance with global regulatory standards (FDA, ISO, EU GMP, ICH, GAMP)
  • Review and approve validation, qualification, calibration, and change control documentation, ensuring systems remain in a state of control and risks to product quality, patient safety, and compliance are effectively managed
  • Support new product introductions, technology transfers, automation, digital solutions, and facility expansions, partnering with Engineering and Operations to embed Quality principles into continuous improvement initiatives
  • Oversee critical utilities, facilities, and metrology programs, ensuring systems are qualified, maintained, monitored, and inspection‑ready, with appropriate mitigation of deviations and out‑of‑tolerance conditions
  • Act as a key Quality partner during audits and inspections, drive standardization and simplification of QA Engineering processes, provide coaching and guidance to technical teams, and influence quality outcomes in a matrixed environment

Requirements

  • Bachelor's degree in Engineering or similar
  • 7+ years of experience in Quality, Engineering, Validation, or Manufacturing within regulated medical device and/or pharmaceutical environments
  • Strong working knowledge of validation/CSV, change control, utilities and facilities qualification, and quality systems
  • Experience supporting regulatory inspections and audits

Nice to have

  • Experience with FDA QMSR / 21 CFR 820, ISO 13485, 21 CFR 210/211, EU GMP, ICH Q7, and GAMP 5
  • Experience supporting combination products or multi-platform manufacturing sites
  • Familiarity with lean, continuous improvement, or business excellence systems in regulated environments

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

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