Quality Analyst

Convatec; São Paulo; Híbrido; BRL 320.000 - 428.000; Tempo integral

Resumo da oferta

A globally recognized medical products company is looking for a Quality Specialist to support global quality initiatives within the Brazilian region. This role demands robust experience in quality management, particularly in regulated sectors such as medical devices and pharmaceuticals. Key responsibilities include managing CAPA deviations and compliance initiatives, engaging with local health authorities, and driving continuous quality improvement. Proficiency in English and a bachelor's degree in relevant fields are essential, along with experience in quality systems audits and regulatory compliance.

Qualificações

• Proven experience in quality roles within regulated industries.
• Strong knowledge in quality systems audits and regulatory compliance.
• Proficiency in quality-related IT systems such as TrackWise and SAP.

Responsabilidades

• Act as quality point of contact for global initiatives in the Andean region.
• Support local health authorities during the review process.
• Lead and support internal and external audits.
• Manage CAPA deviations and risk mitigation activities.
• Provide training and support documentation as needed.

Conhecimentos

Quality systems audits

Regulatory compliance

Communication skills

Analytical skills

Team collaboration

Problem-solving

IT systems proficiency

Formação académica

Bachelor's degree in Pharmacy, Engineering, Chemistry or related field

Industry certifications (e.g., Lead Auditor ISO 13485, Six Sigma)

Ferramentas

SAP

TrackWise

Descrição da oferta de emprego

About Convatec

Pioneering trusted medical solutions to improve the lives we touch : Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions with leading positions in Advanced Wound Care, Ostomy Care, Continence Care and Infusion Care. With more than 10,000 colleagues we provide our products and services in around 90 countries united by a promise to be forever caring. Our solutions provide a range of benefits from infection prevention and protection of at‑risk skin to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE : CTEC).

Position Overview

The Quality Specialist for Brazil plays a critical role in supporting the Global Quality team for Emerging Markets. This position provides strategic and operational quality support particularly in Brazil acting as a key partner to the Quality Manager LATAM and a support to junior analysts. The role ensures alignment with global standards, drives continuous improvement and supports compliance with local regulatory requirements. Success will be measured through effective cross‑functional collaboration, audit readiness and capability development across the region.

Key Responsibilities

• Act as the quality point of contact for global quality initiatives implementation in the Andean region.
• Translate global strategies into actionable plans tailored to local needs.
• Support the Quality Manager LATAM in coordinating quality projects across Brazil and other South Cone countries.
• Interact with local health authorities as needed during the review process to ensure timely regulatory approval for the entity.
• Execute activities for compliance in post‑marketing and distribution. Compile incident reports, complaints and non‑conformities to ensure compliance with local health surveillance requirements and product safety standards. Support investigations into complaints and product safety issues as required.
• Lead and support internal and external audits.
• Ensure compliance with global policies, local regulations and GMP standards.
• Manage CAPA deviations and risk mitigation activities.
• Drive continuous improvement initiatives across the region.
• Provide technical guidance, coaching and training to junior quality analysts as needed.
• Promote knowledge sharing and harmonization of best practices.
• Work closely with Regulatory Affairs, Supply Chain, Operations and other functions.
• Represent the region in global quality forums and contribute local insights to strategic decisions.
• Support the quality system by focusing on adequate handling of non‑conformity activities, corrective and preventive actions.
• Review, update and develop procedures, instructions and quality specifications as needed.
• Monitor the process KPIs (CPMs, NCs, etc.) and present any trends to the leadership and stakeholders to take action if needed.
• Make sure the actions are being supported or referenced to the quality system.
• Promote ideas for continuous improvement of Quality with the end goal of achieving the fulfillment of the systems simplicity.
• Support in several areas where your experience and technical knowledge about the situation can be used.
• Keep communication with other departments in relation to any quality problem.
• Create quality alerts and provide support on the definition of quality criteria when needed.
• Participate in development teams having as their main responsibility the quality and fulfillment of the regulations or other applicable standards.
• Oversee and revise quality systems metrics in collaboration with the LATAM QA Manager.
• Support local regional teams as needed (General Manager, Supply Chain Operations, Finance) for all quality‑related matters.
• Assist in quality‑related activities at logistics operators ensuring compliance with requirements for storage, transportation, product traceability, inspections and releases. Provide training and support documentation as needed. Work with relevant teams to release and maintain updated labeling locally.
• Participate in committees, trainings and awareness to ensure proper competency of their position if applicable.
• Execute job responsibilities with professional care and in compliance with legal requirements and internal standards without compromising the safety of self and others.
• Help drive continuous performance improvement in EHS areas recommending potential improvements to responsible management.
• Participate in identifying opportunities for improvement and implementing the necessary actions to achieve the intended results of their activities.

Authority

Authorized to make decisions related to local quality operations within a defined scope. May review CAPAs, deviations and quality documentation as per QMS guidelines and suggest to the LATAM QA Manager for approval.

Skills & Experience

• Proven experience in quality roles within regulated industries, particularly in medical devices and pharmaceutical companies.
• Strong knowledge and experience in quality systems audits, CAPA deviations and regulatory compliance.
• Warehousing, distribution and logistics are mandatory.
• Proficiency in English is mandatory.
• Experience working in multicultural and regional environments.
• Excellent verbal and written communication, leadership and influencing skills.
• Proficiency in quality‑related IT systems (e.g., TrackWise, SAP, QMS platforms).
• Relationship skills with internal and external clients.
• Ability to work effectively and successfully in a team environment.
• Ability to think critically and creatively.
• Excellent prioritization and organizational skills.
• Ability to be proactive, work independently, manage multiple priorities and ensure quality and consistency in deliveries.
• Excellent analytical skills.
• Computer literacy in MS Word, Excel and PowerPoint.

Qualifications & Education

Bachelor’s degree in Pharmacy, Engineering, Chemistry or related field.
Industry certifications (e.g., Lead Auditor ISO 13485, Six Sigma or equivalent) are a plus.
Membership in professional quality organizations is desirable.

Dimensions of the Team

No direct reports initially but responsible for supporting junior analysts across the region. Works closely with regional and global quality teams.

Principal Contacts & Purpose of Contact

Internal: Quality Manager LATAM; Regional & Global Quality Team; Regulatory Affairs; Supply Chain; Operations; Commercial Teams.
External: Local regulatory authorities, third‑party manufacturers and external auditors.

Travel Requirements

Up to 5–10% travel across the region. Occasional international travel may be required. Overnight travel expected.

Languages

Portuguese: Fluent (speaking, reading and writing)
Spanish: Advanced (speaking, reading and writing)
English: Advanced (speaking, reading and writing)

Working Conditions

Hybrid or remote working model depending on the country (2–3 times/week at the office). Flexible approach to office presence based on business needs.

Special Factors

May require occasional work across time zones.
Participation in global training programs and quality forums.
Flexibility to support urgent quality issues outside standard hours.

Equal Opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Employment Type

Full‑Time

Experience

Years: –

Vacancy

1