Senior Quality Analyst (Based in São Paulo)

Edwards Lifesciences; São Paulo; Presencial; BRL 180 000 - 280 000; Tempo integral

Resumo da oferta

Edwards Lifesciences seeks a Senior Quality professional to support and lead Quality Systems, post-market surveillance, and regulatory compliance across multi-country operations. The role focuses on improving processes, data-driven decision making, and cross-functional collaboration with commercial and field teams.

You will manage field actions, CAPA support, and complaint handling while ensuring adherence to regulatory requirements and product integrity in a global medical device environment.

Qualificações

• Bachelor’s degree in pharmacy, Biomedical Sciences, Engineering, Life Sciences, or related field.
• 5+ years of experience in Quality, Quality Systems, Post-Market Surveillance, Complaint Handling, Regulatory Affairs, or related areas.
• Experience within the medical device or pharmaceutical industries.
• Knowledge of quality systems, complaint management processes, and applicable regulatory requirements.
• Experience analyzing quality data, identifying trends, and supporting investigations and corrective actions.
• Availability to work onsite four days per week.

Responsabilidades

• Applies professional expertise and sound judgment to support quality systems, quality analysis activities, and business outcomes.
• Management of field actions and post-integration regulatory transitions, oversight of multi-country regulatory requirements, and cross-country coordination with senior stakeholders.
• Identifies, leads, and implements business process improvement initiatives for Quality Systems, including developing and enhancing procedures to improve operational efficiency, compliance, and user experience while maintaining process integrity.
• Provides first-level support to Quality System users, including troubleshooting issues related to CAPA and other quality systems, escalating to IT when appropriate.
• Leads projects from initiation through completion, including defining milestones, coordinating resources, and representing Quality on cross-functional teams.
• Serves as a key partner to commercial, field-based, and cross-functional teams, providing guidance and support on quality-related processes, complaint handling, and regulatory requirements.
• Manages post-market surveillance activities, including the receipt, documentation, investigation, trending, and reporting of customer complaints in compliance with applicable regulatory requirements.
• Prepares customer response communications and collaborates with commercial teams to ensure timely and appropriate follow-up on quality-related matters.
• Collects, analyzes, and interprets quality metrics and complaint data, identifying trends, recommending improvements, and supporting data-driven decision-making.
• Participates in complaint review committees and cross-functional business reviews, preparing, analyzing, and presenting quality data and trends to stakeholders.
• Supports field corrective actions, safety communications, recalls, alerts, and other post-market quality activities as required.
• Assists with internal audits, distributor audits, supplier audits, and compliance-related initiatives, ensuring adherence to quality standards and regulatory requirements.
• Determines training needs, develops training materials, and delivers training programs to support effective use of quality systems and processes.
• Recommends changes to documentation associated with Quality Systems and evaluates the effectiveness of implemented improvements.

Conhecimentos

Quality management

Regulatory affairs

Post-market surveillance

CAPA

Data analysis

Cross-functional collaboration

Training delivery

Formação académica

Bachelor's degree in pharmacy, Biomedical Sciences, Engineering, Life Sciences, or related field

Ferramentas

Quality systems software

Descrição da oferta de emprego

Type

Full time

Category

Quality

Location

Job reference

Req-50747

Posted for

18 hours ago

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety.You’llbring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you'll make an impact

• Applies professional expertise and sound judgment to support quality systems, quality analysis activities, and business outcomes.
• Management of field actions and post-integration regulatory transitions, oversight of multi-country regulatory requirements, and cross-country coordination with senior stakeholders.
• Identifies, leads, and implements business process improvement initiatives for Quality Systems, including developing and enhancing procedures to improve operational efficiency, compliance, and user experience while maintaining process integrity.
• Provides first-level support to Quality System users, including troubleshooting issues related to CAPA and other quality systems, escalating to IT when appropriate.
• Leads projects from initiation through completion, including defining milestones, coordinating resources, and representing Quality on cross-functional teams.
• Serves as a key partner to commercial, field-based, and cross-functional teams, providing guidance and support on quality-related processes, complaint handling, and regulatory requirements.
• Manages post-market surveillance activities, including the receipt, documentation, investigation, trending, and reporting of customer complaints in compliance with applicable regulatory requirements.
• Prepares customer response communications and collaborates with commercial teams to ensure timely and appropriate follow-up on quality-related matters.
• Collects, analyzes, and interprets quality metrics and complaint data, identifying trends, recommending improvements, and supporting data-driven decision-making.
• Participates in complaint review committees and cross-functional business reviews, preparing, analyzing, and presenting quality data and trends to stakeholders.
• Supports field corrective actions, safety communications, recalls, alerts, and other post-market quality activities as required.
• Assists with internal audits, distributor audits, supplier audits, and compliance-related initiatives, ensuring adherence to quality standards and regulatory requirements.
• Determines training needs, develops training materials, and delivers training programs to support effective use of quality systems and processes.
• Recommends changes to documentation associated with Quality Systems and evaluates the effectiveness of implemented improvements.

What you will need

• Bachelor’s degree in pharmacy, Biomedical Sciences, Engineering, Life Sciences, or a related field.
• 5+ years of experience in Quality, Quality Systems, Post-Market Surveillance, Complaint Handling, Regulatory Affairs, or related areas.
• Experience within the medical device or pharmaceutical industries.
• Knowledge of quality systems, complaint management processes, and applicable regulatory requirements.
• Experience analyzing quality data, identifying trends, and supporting investigations and corrective actions.
• Strategic mindset, leadership potential, and ambition to develop into a people leadership/managerial role
• Availability to work onsite four days per week.

What else will help you

• Experience in the medical device industry is highly preferred.
• Knowledge of Latin American post-market regulatory requirements and reporting processes.
• Demonstrated ability to build strong relationships and effectively collaborate with diverse stakeholders across commercial, field, operations, and quality teams.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment.
• Hands-on mindset with a willingness to take ownership of a broad range of responsibilities.
• Strong analytical, critical thinking, and problem-solving capabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds.

Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.