Descrição da Vaga
The Plant Quality Assurance Director serves as Management Representative for
the plant in Sao Jose dos Campos - Brazil. He/she leads the Quality Operations
organization, Quality Engineering and Quality System and partners with
Training, Quality Engineering Continues Improvement and Compliance. His/her
primary function is to provide timely information to Management with executive
responsibility and Manufacturing on the status of conformance to requirements.
The Plant QA Director has the necessary
independence, authority and responsibility to maintain the plant in compliance
with all applicable regulatory requirements. He/she maintains systems that
assure only acceptable raw materials are used in processes and that only
acceptable materials or semi-finished and/or finished goods are shipped.
He/she reviews and acts as approval authority or delegated authority,
retaining responsibility for all specifications, validations, and non-
• Serve as Management Representative for the plant
• Coordinate with the Franchise Quality Management System Representative
concerning regulatory directives
• Ensure that the facility remains continually certified to RDC16, ISO, QSR
and any other applicable regulatory certifications
• Ensure that the Quality System is regularly audited/reviewed and that
changes needed are
implemented in a timely fashion
• Serve as a resource by recommending appropriate compliance efforts and
to the Quality System
• Ensure all facility associates are educated in the requirements needed
• Lead the several sections of the Quality Assurance organization, whose
primary function is to provide timely information to Management and
Manufacturing on the status of conformance to requirements
• Provide resources who will:
• Seek and participate in the implementation of, quality improvements
• Determine root causes of non-conformance and recommend corrective actions
• Maintain plant in compliance with Quality System Regulations
• Participate in major plant projects, such as transfer or introduction of new
product or process
• Maintain an effective Documentation Services function
• Maintain systems that assure only acceptable raw materials are used in
processes and that only acceptable materials, semi-finished and/or finished
goods are shipped
• Review and act as approval authority or delegated authority, retaining
responsibility for all specifications,
protocols, validations, fact books, and non-conformances
• Enforces, promotes and observes all safety, industrial hygiene rules and
regulations established by the
• Bachelor Degree and at least 5 years in Quality Assurance and/or Medical
• Minimum of 5 years in supervisory role, preferably QA exempt personnel
• Process Excellence I Six Sigma Certification or equivalent preferred
• Advanced computer and use of software applications
• Database management skills.
• Leadership and management skills.
• Regulatory compliance knowledge and skills.
• Advanced Quality Systems knowledge.
• Product knowledge.
• Interpretation and application of QSR and ISO Standards
• Excellent communication and interpersonal relation skills in local and
• Statistical and analytical problem solving.
• Portuguese and English, fluent