Quality Assurance and Regulatory Specialist

Há 5 dias

Buenos Aires, Brasil beBeeRegulatory Tempo inteiro US$1.000.000 - US$1.200.000
Job Description

This position is responsible for supporting Quality Assurance and Regulatory Affairs elements for our Logistics and Distribution Center.

The Technical Director will provide support on Technovigilance, local labeling processes, document control; quality systems training in accordance with internal procedures, external regulations, and international standards.

  • Evaluates the non-conformances, providing a treatment and solution
  • Confers with representatives of material and service vendors to obtain information related to supply quality, vendor capacity to meet requirements, and vendor quality standards
  • Confers with Teleflex Manufacturing sites about quality assurance aspects of manufactured products
Responsibilities
  • Quality Assurance function through the following activities, but not limited to:
    • Supports global activities related to product, including resolution of regulatory and quality issues
    • Serves on Regional and Corporate level teams as assigned
    • Suggests and debates alternative methods and procedures for solving problems and meeting changing requirements related to importation, storage, distribution, and commercialization
  • Regulatory Affairs function through the following activities, but not limited to:
    • Conducts appropriate research to develop strong regulatory strategies for new products and amendments coming from Regulatory Impact Assessments
    • Assumes full responsibility for project submissions, from guidance/strategies/authoring/obtaining approvals
Requirements
  • BS or BA degree in Engineering, Science, or a related field
  • A minimum of 7 years of professional experience in coordinating logistics, warehousing, customs, and transportation processes (preferably with a medical device manufacturer or large manufacturing-based organization)
  • Complete knowledge with ANMAT, FDA, cGMP, and ISO quality system requirements for a diverse medical device manufacturer
Benefits

Teleflex offers competitive compensation and benefits packages

Opportunities for career growth and development within the company

Others

Leans towards a culture of innovation and teamwork

  • Quality Assurance Specialist

    2 semanas atrás

    Buenos Aires, Brasil beBeeQuality Tempo inteiro R$67.920 - R$95.680

    Quality Assurance SpecialistJob Title: Quality Assurance Specialist Job Summary: We are seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for performing quality control testing, managing laboratory stock, and authoring controlled documents. Responsibilities:Perform routine release testing of finished...

  • Quality Assurance Specialist

    2 semanas atrás

    Buenos Aires, Brasil beBeeQuality Tempo inteiro R$60.000 - R$78.000

    Job DescriptionThe Quality Assurance Specialist will be responsible for implementing, maintaining, and overseeing the Quality Management System (QMS) in local affiliates.Develop and implement QMS policies and procedures to ensure compliance with regulatory requirements and quality standards.Maintain accurate records of audits, inspections, and CAPA.Analyze...

  • Quality Assurance Specialist

    Há 5 dias

    Buenos Aires, Brasil beBeeTest Tempo inteiro R$61.700 - R$86.750

    Quality Assurance SpecialistIn this pivotal role, you will be responsible for ensuring the quality and reliability of our logistics and transportation management solutions.Your expertise in web applications testing metrics and reporting, combined with proficiency in testing tools and frameworks, will enable you to conduct comprehensive testing to guarantee...

  • Quality Assurance Specialist

    2 semanas atrás

    Buenos Aires, Brasil beBeeQuality Tempo inteiro $432.000 - $648.000

    Job Title: Quality Assurance SpecialistWe are seeking a skilled quality assurance specialist to ensure the highest level of software quality.Key Responsibilities:Develop and execute comprehensive test cases to guarantee software integrity.Identify, log, and manage defect reports using efficient issue tracking tools.Implement automated testing solutions to...

  • Quality Assurance Expert

    1 semana atrás

    Buenos Aires, Espírito Santo, Brazil beBeeQuality Tempo inteiro US$40.000 - US$50.000

    Job Title: Quality Assurance SpecialistJob Description:The Quality Assurance Specialist is responsible for ensuring compliance with regulatory requirements, quality standards, and company policies. This role requires the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates.This includes managing quality risk,...

  • Quality Assurance Specialist

    Há 4 dias

    Buenos Aires, Brasil beBeeAssurance Tempo inteiro $1.800.000 - $2.200.000

    Job Title: Quality Assurance Specialist">We are looking for a skilled and detail-oriented Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our software products by designing and executing test cases, identifying and logging bugs, and implementing automated testing.">About...

  • Senior Quality Assurance Specialist

    2 semanas atrás

    Buenos Aires, Brasil beBeeQuality Tempo inteiro $2.425.554 - $3.623.321

    Job Description">This role is responsible for providing support to the Quality Assurance and Regulatory Affairs departments within the company's logistics and distribution center.The Technical Director will provide guidance on Technovigilance, local labeling processes, document control, and quality systems training in accordance with internal procedures,...

  • Quality Assurance Specialist

    2 semanas atrás

    Buenos Aires, Espírito Santo, Brazil beBeeQuality Tempo inteiro R$90.000 - R$120.000

    Job OverviewWe are seeking a Quality Assurance Specialist to join our team.The Quality Assurance Specialist will be responsible for ensuring the quality of our products and services, as well as implementing and maintaining our Quality Management System (QMS).This role requires strong knowledge of GxP regulations and quality standards, as well as excellent...

  • Quality Assurance Consultant

    4 semanas atrás

    Buenos Aires, Brasil PharmEng Technology Tempo inteiro

    Join to apply for the Quality Assurance Consultant role at PharmEng Technology Join to apply for the Quality Assurance Consultant role at PharmEng Technology About The Job Quality Assurance ConsultantJob Summary: The Quality Assurance Consultant is responsible for the implementation, maintenance, and oversight of the Quality Management System (QMS) in...

  • Senior Quality Assurance Specialist

    2 semanas atrás

    Buenos Aires, Brasil beBeeQuality Tempo inteiro R$50.000 - R$80.000

    Job OverviewWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team in Buenos Aires, Brazil. The ideal candidate will have a strong background in Well Head Equipment within the Oil & Gas Industry.Key Responsibilities:Review material certificates and ensure compliance with relevant industry standards.Conduct inspections of...