Quality Assurance, Associate Manager

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

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

As the Associate Quality Manager for a medical device manufacturer, this position is primarily responsible for assuring compliance to all regulatory requirements. This position will support Quality operations for Latin America (Brazil, Colombia, Argentina, Mexico, Peru, Chile) and will have responsibility for the following: CAPA, NCs, audits, recalls and complaints at a minimum.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Fulfill the responsibilities of the Technical Responsible Person for Brazil and other required quality roles per LATAM (Colombia, Argentina, Mexico, Peru, Chile) regulations. This includes maintaining QMS for Brazil.
• Work in partnership with the LATAM 3rd party distributors to ensure all activities and operations are carried out in compliance with local, state, federal, and international regulations and laws governing the quality operations. This includes management of Distributor Quality Agreements for LATAM.
• Oversee reporting activities (complaints and field safety corrective actions) to ANVISA and LATAM (Colombia, Argentina, Mexico, Peru, Chile) market authorities.
• Responsible for leading all site QA audits, including hosting auditors onsite as required as well as responding to all audit/documentation requests.
• Other Duties as assigned

DESIRED MINIMUM QUALIFICATIONS

• Education: 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

Experience

• 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.
• Uses expertise to improve operational efficiencies and meet compliance requirements.
• Strong statistical analysis skills.
• Strong working knowledge Microsoft Office programs (Word, Excel, Access, PowerPoint).
• Experience working in Oracle, Agile and TrackWise systems preferred.
• Maintain and improve the local Quality Management System in accordance with Brazilian and international standards.
• Partners with corporate quality and regulatory teams to ensure global alignment of qualities policies, procedures and agreement.
• Conduct internal and external audits to ensure compliance with Quality Standards (ANVISA, INMETRO, MDSAP, ISO 13485).
• Manage tracking, reportability, and closure of complaints, nonconformities (NCs), Corrective/Preventive Actions (CAPAs) and Recalls reporting within a timely manner in accordance with internal procedures and external requirements.
• Support global NCs and CAPAs to resolve quality issues which impact Latam markets.
• Ensure proper documentation and record keeping for quality processes, both at the Brazilian site and with any 3rd party logistics providers in Latin America.
• Organize and run Brazilian Management Review meetings.
• Provide training to local staff and distributors on quality standards.
• Host for any audits that may need to take place at the Brazilian site and support international team as needed.
• Ensure that all quality activities comply with the requirements of all applicable laws and are fully consistent with approved labeling and all applicable product authorizations.