LatAm Quality Assurance Manager

integralife; United States; Remote; USD 35,000 - 46,000; Full time

Job summary

integralife is seeking an Associate Quality Manager to ensure regulatory compliance for LATAM, with a focus on Brazil. You will oversee CAPAs, NCs, audits, recalls, and complaints, and partner with LATAM distributors to maintain QMS and compliance with ANVISA and other authorities.

The role requires a strong background in medical devices, regulatory audits, and cross-functional collaboration across LATAM teams.

Qualifications

• Bachelor’s degree in a scientific, engineering, or equivalent discipline with 8+ years of experience or a Master’s with 5+ 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 written and verbal communications.
• Must live in Brazil.
• Experience with Medical Devices and Instruments is required.

Responsibilities

• Fulfill the responsibilities of the Technical Responsible Person for Brazil and LATAM regulations.
• Maintain QMS for Brazil and partner with LATAM distributors to ensure compliance.
• Oversee reporting to ANVISA and LATAM market authorities.
• Lead all site QA audits and respond to audit/documentation requests.
• Manage tracking, reportability, NCs, CAPAs, and recalls per procedures.

Skills

Portuguese

Spanish

English

Quality management

Regulatory compliance

Auditing

LATAM experience

Documentation

Education

Bachelor’s degree in science/engineering

Master’s degree +5 years experience

ASQ CQA certification (desirable)

Tools

Oracle

TrackWise

Agile

Microsoft Office

Job description

integralife is seeking an Associate Quality Manager to ensure regulatory compliance for LATAM, with a focus on Brazil. You will oversee CAPAs, NCs, audits, recalls, and complaints, and partner with LATAM distributors to maintain QMS and compliance with ANVISA and other authorities.

The role requires a strong background in medical devices, regulatory audits, and cross-functional collaboration across LATAM teams.