REGULATORY AFFAIRS/QUALITY ASSURANCE MANAGER (RA & QA MGR)
GLOBAL HEAD HUNTERS GROUP LLC - SAO PAULO (Brasil)
Descrição da vaga
Global Head Hunters Group LLC., A premier employment firm specializing in the placement of professionals in the Administrative, Financial and Legal Industries Nationally and Internationally is currenlty searching for an RA & QA Manager. Our client is a Fortune 500 Company, leader in the manufacture and distribution of Medical Technology. This position will be based in Sao Paulo.
The main objective of this position is to implement and maintain Quality Assurance Systems and Activities within FDA/Local Regulatory guidelines.
To ensure regulatory compliance regarding incidents of injury, recall,
and product registration as required by regulatory agencies.
ACTIVITIES:
The RA & QA Manager must act as a Management Representative in terms of creating awareness of customer requirements throughout the organization.
To create, implement easy accessible, user friendly and up to date quality system documentation in line with other offices within the organization.
Train employees about company practices on vigilance and regulatory aspects
Manage customer complaint handling system on services
PEOPLE MANAGEMENT:
To manage and motivate the RA/QA team in order to fulfill the business objectives and achieve the highest level of customer satisfaction
To attract and retain quality employees with the best skills and qualifications to ensure that the Company standards and values are met and exceeded.
To carry out performance appraisals with all direct reports and to ensure that both individual and organization development and training needs are met.
COMPLIANCE:
Must conduct all business and affairs in compliance with all laws and regulations, including the Foreign Corrupt Practices Act (FCPA), Company Code of Conduct, and in accordance with the highest ethical
standards.
REGULATORY AFFAIRS
Responsible for developing, modifying, and executing
regulatory related company guidelines and procedures.
•Maintains products new and current registrations
according to local regulatory policies.
QUALITY ASSURANCE
•Defines, specifies, and/or approves of the
implementation of standards, methods, and procedures for inspecting, testing,
and evaluating the precision, accuracy and reliability of company products.
•
Supports the International Recall Process.
•
Responsible for failure analysis associated with the
complaint management system, including documentation of failures, causes of
failures, and identification of corrective actions.
•
Conductst internal Quality Assurance compliance
audits and communicate results.
•
Ensure MDR investigations and filings, communication
of complaint investigation to Sales Rep/Customers, internal regulatory and
quality audits, complaint trend analysis are completed and evaluated in
accordance with regulatory requirements.
EDUCATION & OTHER BASIC REQUIREMENTS:
Bachelors of Science Degree in Engineering or
Science
2 – 4 years as a Manager of a QA function or
equivalent experience.
Microsoft Office, English (written & oral),
Formal training in Quality Assurance.
Excellent analytical skills and interpersonal skills.
Demonstrated effective managerial skills.
Interested and qualified candidates please submit your Resume via email to mluque@globalheadhunters.net
Habilidades e experiências desejadas
ENGLISH- ORAL AND WRITTEN. SPANISH A PLUS.
Descrição da empresa
Global Head Hunters Group LLC., is a premier employment firm specializing in the placement of professionals in the Administrative, Financial and Legal Industries, nationally and internationally.
Informações adicionais
Publicado:30 de novembro de 2011
Tipo:Tempo integral
Experiência:Pleno-sênior
Funções:Controle de qualidade
Setores:Dispositivos médicos
Remuneração:R$150,000 TO R$230,000 INCLUDES BONUS
Código da vaga:2233636