Quality Assurance Analyst – Andean Region

Bogotá DC
Permanente
Tiempo completo

Hace 23 días

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.comAbout the role:The Quality Specialist for the Andean Region plays a critical role in supporting the Global Quality team for Emerging Markets. This position provides strategic and operational quality support across multiple countries in the Andean region particularly Colombia, Peru, and Chile, acting as a key partner to the Quality Manager LATAM and a mentor 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 Specialist will have a key position to support quality activities in the Andean region acting as the regional specialist part of Global QA Team for GEM, 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 Responsabilities:Act as the quality point of contact for global quality initiatives implementation at the Andean region.Translate global strategies into actionable plans tailored to local needs.Support the Quality Manager LATAM in coordinating quality projects across Colombia, Peru, Chile, and other Andean 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 being focused 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 trending to the leadership and stakeholders to take actions if needed.Make sure the actions are being supported or referenced to the quality system.Promote ideas for continuously improvement of Quality with the end achieve the fulfilment across of the systems simplicity.Support at several areas where your experience and technical knowledge about the situation can be usefully.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 main responsibility the quality and fulfilment with the regulations or other applicable standards.Overseen and revision of quality systems metrics, in collaboration with 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 labelling 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 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:Key competencies and characteristics candidates need to demonstrate to help build our diverse, inclusive culture and to be successful in the role. Examples include:

Minimum 5 years of experience in quality roles within regulated industries (mainly medical devices and pharmaceutical).
Strong knowledge and experience in quality systems, audits, CAPA, deviations, and regulatory compliance.
Warehousing, distribution, and logistics background is a must.
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 skill 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 field.
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 10-15% travel across the Andean region.
Occasional international travel may be required.
Overnight travel expected.

Languages

English C1 required

Working Conditions

1 day per week with a flexible approach to office presence based on business needs.

Beware of scams online or from individuals claiming to represent ConvatecA formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at .Equal opportunitiesConvatec 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.Notice to Agency and Search Firm RepresentativesConvatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Already a Convatec employee?If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!

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