Gerente sr quality assurance – São José dos Campos/SP

Responsabilidades

• Responsible for managing the Quality Operations (Supply Chain) team within Brazil MedTech Surgery site.
• Responsible for ensuring, maintaining, and supporting the company’s quality management system, complying with regulatory standards and meeting quality, health, safety, and environmental standards.
• Responsible for ensuring the quality of existing products and processes, ensuring that changes are documented and do not negatively impact product performance and quality.
• Responsible for identifying potential hazards to people, property, and the environment, complying with the procedures set forth by the company and applicable regulations.
• Manage the organization’s financial resources, leading and influencing business decisions, both current and strategic, to maximize profit results and capital efficiency, by properly executing and meeting Compliance requirements.
• Responsible for the compliance with the policies, norms, and procedures in effect at the company, as well as for their modification and updating, if necessary.
• Responsible for the performance and development of subordinates.
• Ensure the image of the company’s products with customers, suppliers, and the market in general, by guiding and monitoring the policies and guidelines for quality, within the needs of the business and national and international standards.
• Contribute to the adoption by all levels of the company – MedTech Brazil, of a Quality culture, enabling better results in the performance of various activities through the dissemination of concepts, programs, and procedures that involve changes in attitudes/behaviors of the company’s human resources regarding quality.
• Ensure that the products supplied by the company – MedTech Brazil meet customer expectations, by implementing and maintaining a Quality System that contains standards for product quality as well as procedures for achieving the same.
• Develop the area’s Budget planning, as well as appropriately utilize the financial resources provided.
• Ensure the proper disposition of products involved in non-conformances and other issues identified in manufacturing.
• Support and provide appropriate resources for the proper investigation of non-conformances, market complaints, escalations, CAPAs.
• Establish and maintain quality programs, procedures, and controls. Ensure that product performance and quality comply with the company and regulatory standards.
• Provide support to subordinates and/or team to assist in meeting established plans and/or resolve technical and operational problems.
• Formulate and maintain quality objectives and ensure they align with other managers to ensure product reliability and minimize costs.
• Determine direction for projects and modifications on production lines. Approve requests for customization and product modifications.
• Ensure that products meet and/or exceed regulatory and company standards.
• Provide quality support for supplier quality management, when necessary.
• Support quality audits in production or systems, when appropriate.
• Review audit reports and other business reports and propose corrective action.
• Lead and/or participate in projects that continuously improve the performance of processes that produce products, aiming to meet customer expectations.
• Responsible for communicating business-related problems or opportunities to the next management level.
• Responsible for ensuring that subordinates follow all company guidelines related to Environmental, Health, and Safety practices and that all necessary resources are available and in good condition, if applicable.
• Responsible for ensuring individual and company compliance with all Federal, State, local, and company regulations, policies, and procedures, including ISO and any other regulations of the sites we supply.
• Empower team to act with speed, agility, and accountability.

Requisitos

• QUALIFICAÇÕES MÍNIMAS
  • Bachelor’s degree in Pharmacy/Chemistry/Biosciences, Engineering or equivalent field.
  • Minimum of 8 years of experience working in Quality, Manufacturing or related areas of a Pharmaceutical, Cosmetic or Medical device regulated environment.
  • Large experience in leading projects.
  • Demonstrated effective people management.
  • Large knowledge in Supply Chain.
  • Fluent in English.
  • Verbal and written communication skills.
  • Knowledge of Regulatory Standards.
  • Skills in prioritizing, follow-up, and controlling results and metrics.
  • Knowledge in project management, problem-solving, quality tools, and Office.
  • Extensive understanding of Quality Assurance, Quality Control and Compliance.
  • Ability to recognize and build support for change, engage in constructive conflict, and build partnerships both internally and externally.
  • Ability to work in complex environments.
  • Presentation skills, training/education methodologies.
• QUALIFICAÇÕES PREFERENCIAIS
  • Master’s degree in Quality, Regulatory, People Management, or related fields.
  • Spanish.
  • Desired certification as Green or Black Belt in Lean and/or Six Sigma.

Marcado como: Assuntos Regulatórios, Auditoria, BPF, Compliance, Controle de Qualidade, Dispositivos Médicos