Descrição:
Appropriate qualifications, e.g. degree level in a technical subject, membership of relevant national / international bodies, etc.

Experience in a quality function in a regulated industry (medical devices/pharmaceuticals).

Experience and knowledge of Quality Management Systems including ISO 13485, RDC 565 or other regulation that may supersede it with regards Good Manufacturing Practices per ANVISA, and other local country regulations in South America

Good communications skills, including clear and concise report writing.

Must be fluent in Brazilian Portuguese and English; fluent in Spanish is a plus.

Strong attention to details and good organizational skills

Must be capable of working across departments.

Ability to multitask and prioritize between multiple projects.

Willingness to learn and propensity to work with minimal supervision.

Knowledge of Share Point (Info Point), Microsoft Office Software

Drive and manage the current QMS implementation project through to completion and on time.

Continuously improve the QMS by ensuring the quality system requirements are effectively established, implemented, and maintained.

Author, revise, and maintain QMS documents & records according to Elekta s Quality Management System

Drive LATAM involvement with global QMS harmonization and streamline redundant global and regional procedures.

Responsible for Portuguese translations of QMS documents

Responsible for maintaining and trending Quality metrics

Implement and manage Supplier Qualification and Management program.

Coordinate and help drive process improvement projects throughout all departments.

Ensure the promotion of awareness of regulator, and customer requirements throughout the organization Support Brazil departments (Customer Satisfaction, Order Fulfilment, Field Servicing, etc,) regarding Quality activities and Quality System navigation.

Educate and train personnel to execute activities (e.g., order planning and fulfilment, field servicing) in full accordance with GDP, Quality Manual, ISO 13485, and RDC 16 to ensure real-time compliance.

Support employee training program and training records maintenance.

Perform investigations where required (Complaints. Non-conformances, CAPA)

Process non-conformances related to processes controlled in Brazil per Elekta 5 QMS requirements.

Execute, review, and assist with all stages of the CAPA process (investigation, plan development and implementation. verification of effectiveness)

Support Global Post Market Surveillance (GPMS) activities were requested (i.e. complaint handling guidance and recall notifications support) in LATAM as necessary.

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