Analista de Qualidade Sênior

Abbott Laboratories; São Paulo; Presencial; BRL 50.000 - 70.000; Tempo integral

Resumo da oferta

A global healthcare leader is seeking a Quality Analyst in São Paulo to oversee quality systems for medical devices. This role involves ensuring compliance with regulatory requirements, developing a new Quality System, and leading internal and external audits. The ideal candidate holds a Bachelor's degree and has a minimum of 5 years in Quality Assurance or Regulatory Affairs, particularly in Medical Devices. Fluent Portuguese and English are essential for this position and contributes to enhancing quality and compliance standards.

Serviços

Career development with an international company

Medical and Dental Assistance

Life Insurance

Flexible work policies

Qualificações

• Minimum of 5 years in Quality Assurance or Regulatory Affairs, preferably in Medical Devices.
• Strong understanding of ISO standards and regulatory requirements.
• Experience leading internal and external audits.

Responsabilidades

• Provide quality oversight of product Design History Records (DHRs).
• Ensure compliance with repair, maintenance, and validation processes.
• Develop and implement a new Quality System for the site.
• Lead continuous improvement initiatives for compliance.
• Conduct internal and external audits, ensuring inspection readiness.
• Manage CAPA investigations and resolutions.

Conhecimentos

Quality Assurance

Regulatory Compliance

Root Cause Analysis

Fluent in Portuguese

Fluent in English

Formação académica

Bachelor's degree in pharmacy, Biomedical Engineering, Production Engineering, Biomedicine, or related fields

Descrição da oferta de emprego

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• Benefits such as Medical and Dental Assistance, Life Insurance, Private Pension Plan, Medication Subsidy, Discount on Abbott stock purchases, among others.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
• We offer flexible work policies that allow a healthy balance between personal and professional life
• We invest in the development of our employees through training and growth opportunities
• We foster an environment where every voice is heard and valued

The Opportunity

As the Quality Analyst, you’ll have provide comprehensive leadership for the Brazil FRC and is responsible for ensuring that all activities within the Repair and Validation Center (CRV) for medical devices are fully compliant with applicable regulatory requirements, quality standards, and corporate policies.

This position will be responsible to design, develop and implement a new and independent quality system for the FRC. Key responsibilities of this role include final release and oversight of Design History Records (DHRs), management of quality systems and controls, and monitoring of key performance indicators to drive continuous improvement. The position oversees quality related training, maintains inspection readiness, and leads internal and external audits, including environmental compliance activities such as hazardous waste management and water monitoring. It supports resource planning, maintains labor standards for quality, provides technical consultation for global refurbishment initiatives. Additionally, the role is responsible for CAPA investigations, applying structured methodologies to ensure effective root cause analysis and resolution.

What You’ll Do

• Responsible for final release and quality oversight of product Design History Records (DHRs) for all refurbished and repaired instruments. Provides quality assurance for spare part evaluations and rebuilds within the FRC, ensuring compliance. Accountable for verifying that all products released from the site meet established requirements.
• Ensure full compliance of repair, maintenance, and validation processes for medical devices with RDC 665/2022 and other relevant regulations (when applicable).
• Responsible to develop a new and independent Quality System for the site to ensure compliance to ISO standards and Core DX Division requirements. This includes oversight of processes overseeing nonconforming product, supplier management and auditing, document control, incoming inspection and release, and integration of regulatory requirements. Also accountable for managing the Master Validation Plan overseeing the site calibration, preventive maintenance and validation programs.
• Oversees process monitoring and Management Review activities, ensuring that all key performance indicators (KPIs) are tracked effectively. Leads the development and execution of continuous improvement initiatives to improve efficiencies while also ensuring compliance.
• Oversees all quality related training programs for site personnel. Ensures training content aligns with quality and regulatory requirements.
• Ensures the site is inspection-ready at all times. Serves as the site lead for internal and external audits, including regulatory inspections. Manages hazardous waste compliance, conducts internal inspections, water monitoring and gap assessments. Implements changes when necessary.
• Maintains labor standards and supports resource planning for Quality support activities.
• Provides technical quality consultation and project support for the development and global implementation of refurbishment programs. Supports strategic initiatives related to the global redeployment of used instruments and parts, ensuring alignment with quality and regulatory requirements.
• Responsible for all CAPA related investigations, applying structured quality tool methodologies to support effective root cause analysis and resolution. Ensures timely and compliant closure of CAPAs to drive continuous improvement.

Required Qualifications

Bachelor’s degree in pharmacy, Biomedical Engineering, Production Engineering, Biomedicine, or related fields.

Preferred Qualifications

Minimum of 5 years in Quality Assurance or Regulatory Affairs, preferably within the Medical Devices or Diagnostics industry.

Fluent in Portuguese and English (written and spoken).