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.