Quality Assurance, Associate Manager

Job description

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. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Assurance, Associate Manager based in Brazil. This is a strategic quality role supporting medical device operations across Brazil and multiple Latin American markets.You will help ensure that quality systems, processes, and products remain compliant with stringent regulatory requirements.The role combines quality assurance leadership with hands-on responsibility for CAPAs, nonconformities, audits, complaints, and recalls.You will collaborate closely with distributors, corporate quality and regulatory teams, and local stakeholders across the region.As the quality lead for Brazil, you will play an important role in maintaining the local QMS and supporting regulatory readiness.The position offers the opportunity to influence operational excellence while protecting product quality and patient outcomes.This is a remote, cross-functional environment suited to an experienced medical device quality professional with strong regional expertise.