LATAM Quality Assurance Leader: Compliance & CAPA

Integra LifeSciences; Delft; On-site; EUR 90,000 - 125,000; Full time

Job summary

Integra LifeSciences is seeking an Associate Quality Manager to assure regulatory compliance across LATAM regions, including Brazil and distributor oversight. The role entails maintaining QMS, leading audits, and managing CAPAs, NCs, recalls, and complaints to ensure alignment with ANVISA and international standards.

The ideal candidate has a scientific/engineering background, 8+ years of experience (or Master + 5+ years), and fluent Portuguese, Spanish, and English.

Qualifications

• Bachelor’s degree in a scientific/engineering field; 8+ years of experience or Master degree 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

Responsibilities

• Fulfill responsibilities of the Technical Responsible Person for LATAM regions, including maintaining QMS for Brazil
• Lead site QA audits and respond to audit/documentation requests
• Oversee reporting to LATAM authorities (ANVISA, regional bodies)
• Manage CAPAs, NCs, recalls, and complaint handling
• Maintain and improve local QMS per Brazilian and international standards
• Train staff and distributors on quality standards

Skills

Quality Assurance

Regulatory compliance

Analytical skills

Communication

Education

Bachelor’s degree in a scientific/engineering field

Master's degree + 5+ years experience

ASQ CQA certification desired

Tools

Oracle

TrackWise

Agile

MS Office / Excel

Job description

Integra LifeSciences is seeking an Associate Quality Manager to assure regulatory compliance across LATAM regions, including Brazil and distributor oversight. The role entails maintaining QMS, leading audits, and managing CAPAs, NCs, recalls, and complaints to ensure alignment with ANVISA and international standards.

The ideal candidate has a scientific/engineering background, 8+ years of experience (or Master + 5+ years), and fluent Portuguese, Spanish, and English.