Quality Assurance, Associate Manager

Accountabilities:

• • Lead and maintain the local Quality Management System in Brazil, ensuring alignment with Brazilian, Latin American, and international quality and regulatory requirements.
  • Fulfill the responsibilities associated with the Technical Responsible Person in Brazil and other applicable quality roles across LATAM.
  • Partner with third-party distributors across Brazil, Colombia, Argentina, Mexico, Peru, and Chile to ensure compliant quality operations and maintain Distributor Quality Agreements.
  • Oversee complaint handling, nonconformities, CAPAs, recalls, and field safety corrective actions, including timely reporting to ANVISA and other applicable market authorities.
  • Lead internal and external quality audits, including audit preparation, hosting auditors, responding to documentation requests, and coordinating follow-up activities.
  • Ensure quality activities comply with applicable regulations and remain consistent with approved labeling and product authorizations.
  • Collaborate with global quality and regulatory teams to align regional policies, procedures, agreements, and quality initiatives.
  • Support global nonconformities and CAPAs affecting Latin American markets and drive effective resolution of quality issues.
  • Maintain accurate quality records and documentation for Brazilian operations and third-party logistics providers across LATAM.
  • Organize and facilitate Brazilian Management Review meetings and provide quality training to local employees and distributors.
  • Analyze quality data, identify root causes and trends, prepare reports, and recommend improvements that strengthen compliance and operational efficiency.

  Requirements:

  • Bachelor’s degree in a scientific, engineering, or related discipline, with 8+ years of relevant experience; alternatively, a Master’s degree with 5+ years of experience or an equivalent combination of education and experience.
  • Current registration with the Regional Professional Council in São Paulo, Brazil.
  • Proven professional experience in the medical device and/or medical instrument industry is required.
  • Strong knowledge of Brazilian and international quality standards and regulations, including ANVISA, INMETRO, MDSAP, and ISO 13485.
  • Experience managing Quality Management Systems, audits, complaints, CAPAs, nonconformities, recalls, and regulatory reporting.
  • Fluency in Portuguese, Spanish, and English, both written and verbal, to support communication across LATAM and international teams.
  • Strong analytical and statistical capabilities, with the ability to interpret data, identify causes, draw conclusions, and develop actionable recommendations.
  • Excellent written and interpersonal communication skills, with the ability to collaborate effectively with distributors, auditors, regulators, and cross-functional stakeholders.
  • Strong working knowledge of Microsoft Office, particularly Word, Excel, Access, and PowerPoint.
  • Experience with systems such as Oracle, Agile, and TrackWise is preferred.
  • ASQ Certified Quality Auditor (CQA) certification is desirable.
  • Ability to work independently, manage multiple priorities, and maintain high standards of accuracy and regulatory compliance.
  • Must be based in Brazil.

  Benefits:

  • Fully remote work arrangement within Brazil.
  • Opportunity to work across multiple Latin American markets in a high-impact quality leadership role.
  • Exposure to international regulatory frameworks, medical device quality systems, and cross-functional global teams.
  • Professional development through collaboration with experienced quality and regulatory specialists.
  • Opportunity to directly contribute to product quality, regulatory compliance, and outcomes that affect patients.
  • Inclusive and collaborative work environment focused on professional growth and meaningful impact.
  • Benefits and employment conditions are provided according to applicable local policies and employment terms.