Senior Quality Analyst

4 semanas atrás

São Paulo, Brasil MaxSearch Tempo inteiro

Senior Quality Analyst is a fulltime position that is responsible for applying Quality principles and techniques in the planning, development, and implementation of quality system processes and procedures to support the various day to day functions of CIA, including order fulfilment and field installation/servicing operations. This person must adhere to controls as specified in CIA global Quality Management System and support compliance with ISO 13485, ROC 665 or other regulations that may supersede it with regards Good Manufacturing Practices per ANVISA and other applicable medical device regulations in Region South America (RSA) as applicable.

Job Location: The position will be based in Brazil and is office based with hybrid working opportunities.

Travel Requirements: The position may require travel as needs dictate.

Management Role: LATAM delegated Management Representative.

Responsibilities
  1. Drive and manage the current QMS implementation project through to completion and on time.
  2. Continuously improve the QMS by ensuring the quality system requirements are effectively established, implemented, and maintained.
  3. Author, revise, and maintain QMS documents & records according to Elekta's Quality Management System.
  4. Drive LATAM involvement with global QMS harmonization and streamline redundant global and regional procedures.
  5. Responsible for Portuguese translations of QMS documents.
  6. Responsible for maintaining and trending Quality metrics.
  7. Implement and manage Supplier Qualification and Management program.
  8. Coordinate and help drive process improvement projects throughout all departments.
  9. Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.
  10. Support Brazil departments (Customer Satisfaction, Order Fulfilment, Field Servicing, etc.) regarding Quality activities and Quality System navigation.
  11. 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.
  12. Support employee training program and training records maintenance.
  13. Perform investigations where required (Complaints, Non-conformances, CAPA).
  14. Process non-conformances related to processes controlled in Brazil per Elekta's QMS requirements.
  15. Execute, review, and assist with all stages of the CAPA process (investigation, plan development and implementation, verification of effectiveness).
  16. Support Global Post Market Surveillance (GPMS) activities were requested (i.e., complaint handling guidance and recall notifications support) in LATAM as necessary.
Qualifications
  1. Appropriate qualifications, e.g. degree level in a technical subject, membership of relevant national / international bodies, etc.
  2. Experience in a quality function in a regulated industry (medical devices/pharmaceuticals).
  3. 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.
  4. Good communications skills, including clear and concise report writing.
  5. Must be fluent in Brazilian Portuguese and English; fluent in Spanish is a plus.
  6. Strong attention to details and good organizational skills.
  7. Must be capable of working across departments.
  8. Ability to multitask and prioritize between multiple projects.
  9. Willingness to learn and propensity to work with minimal supervision.
  10. Knowledge of SharePoint (InfoPoint), Microsoft Office Software.
Additional Information

Competitive Salary: Aligned with industry standards and adjusted for local market conditions.

Health and Dental Insurance: Comprehensive coverage for employees and their dependents.

Life Insurance: Financial security for employees' families in case of unforeseen events.

Meal and Transportation Allowance: Subsidies for daily meal expenses and commuting costs.

Performance Bonuses: Annual or quarterly bonuses based on individual and company performance.

Paid Time Off: Generous vacation days, personal leave, and paid sick leave.

Professional Development: Opportunities for training, certifications, and continued education.

Flexible Working Arrangements: Options for hybrid or remote work, depending on the role.

Retirement Plan: Company-sponsored pension or retirement plan with possible matching contributions.

Wellness Programs: Access to wellness resources, such as gym memberships, mental health support, and employee assistance programs.

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