Quality Assurance Analyst

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). To learn more please visit http://www.convatecgroup.com

Position Overview:

The Quality Assurance Analyst for Brazil plays a critical role in supporting the Global Quality team. This position provides strategic and operational quality support particularly in Brazil acting as a key partner to the LATAM Quality Head 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.

The Quality Assurance Analyst will have a key position to support quality activities in Brazil acting as the regional specialist part of Global QA Team, and responsible to assure the compliance for regulations, standards, QMS internal procedures on new projects, process improvements, risk management and customer complaints investigations at regional level. Needs to be able to work independently, quality focused, and proactive.

Key Responsibilities:

• Act as the quality point of contact for global quality initiatives implementation in the Brazil region.

• Translate global strategies into actionable plans tailored to local needs.

• Support the LATAM QA Head in coordinating quality projects in Brazil.

• 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, SCARs, 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, quality specification as needed.

• Monitor the process KPIs (CPMs, NCs, etc.) and present any trend to the leadership and stakeholders to take actions if needed.

• Make sure the actions are supported or referenced to the quality system.

• Promote ideas for continuous improvement of Quality with the end achieve the fulfillment across of the systems simplicity.

• Support at several areas where your experience and technical knowledge about the situation can be useful.

• 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.

• Participating in development teams have as main responsibility quality and fulfillment with the regulations or other applicable standards.

• Overseen and revision of quality systems metrics, in collaboration with LATAM QA Head.

• 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, training, 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.

Skills & Experience:

• Minimum of 5 years of experience in quality roles within regulated industries (mainly medical devices and pharmaceuticals).

• Strong knowledge and experience in quality systems, audits, CAPA, SCARs, deviations, and regulatory compliance.

• Warehousing, distribution, and 3PL logistics background is 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., Track Wise, 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, managing multiple priorities, ensuring 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 fields is mandatory.

• Industry certifications (i.e. Lead Auditor ISO 13485, Six Sigma, or equivalent) are a plus.

• Membership in professional quality organizations is desirable.

Travel Requirements:

• Up to 5-10% travel across the region.

• Occasional international travel may be required.

• Mandatory weekly visits to Convatec 3PL/WH in Jundiai-SP (transportation by taxi paid by company).

Languages:

• Portuguese (fluent)

• Spanish (advanced)

• English (advanced or fluent preferred)

Working Conditions:

• Hybrid or remote working model (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.

Ready to join us?
 

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life

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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.

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