Assure compliance to all regulatory requirements
Support Quality operations for Latin America (Brazil, Colombia, Argentina, Mexico, Peru, Chile)
Fulfill the responsibilities of the Technical Responsible Person for Brazil and other required quality roles per LATAM regulations
Maintain QMS for Brazil
Work in partnership with the LATAM 3rd party distributors to ensure compliance with regulations
Oversee reporting activities (complaints and field safety corrective actions) to ANVISA and LATAM authorities
Lead all site QA audits, including hosting auditors onsite
Respond to all audit/documentation requests

Bachelor’s degree in a scientific, engineering, or equivalent discipline
8+ years of experience or equivalent education and years of experience or Master degree with 5+ years of experience or equivalent education and years of experience
Current registration with the Regional Professional Council in São Paulo – Brazil
ASQ Certification as a CQA desired
Fluent in Portuguese, Spanish and English for both written and verbal communications
Prior experience with Medical Devices and Instruments is required
Strong analytical skills, exceptional writing, and interpersonal relationship skills
Fully competent in all conventional aspects of the subject matter, functional area, and assignments
Compiles and analyzes data, identifies causes, draws conclusions, generates reports
Strong statistical analysis skills
Strong working knowledge Microsoft Office programs (Word, Excel, Access, PowerPoint)
Experience working in Oracle, Agile and TrackWise systems preferred.

Changing lives and building careers
Chance to do important work that creates change and shapes the future of healthcare
Support and challenge from dynamic and inspiring people

Quality Assurance, Associate Manager

Key skills