Analyst Quality
Há 21 horas
Ensure that Edwards has the warehouse distribution operation managed in compliance with local and international regulations.
Need to travel two times per week to warehouse location (Cajamar - SP).
**Key Responsibilities**:
- Develop, evaluate and analyze moderately complex technical information and data related to Quality department, Field Corrective Action, Stop Shipment, identifying trends and driving factors, and recommending course corrections.
- Draft updates to Quality procedures, and conduct reviews to finalize procedures
- Contribute process knowledge to, and develop proposed modifications to resolve open issues on Quality and Supply Chain
- Identify root cause and suggest corrective actions in initial non-conformance investigations
- Develop and present training materials for quality system related processes to Distribution Center
- Other duties assigned by Leadership; Support corporate level project management.
**Education and Experience**:Bachelor's Degree in Related field Required
Previous related experience Required
Experience working in a medical device, healthcare, or a related environment Preferred
**Additional Skills**:
- Project Management Skills
- Good computer skills in MS Office Suite
- Ability to read, write and speak English fluently, knowledge of the Spanish language required and/or other language (e.g. German, French, Portuguese) pereffered
- Good written and verbal communication skills including negotiating and relationship management skills
- Good problem-solving and critical thinking skills
- Moderate knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
- Full knowledge of Good Documentation Practices (GDP)
- Good understanding of quality regulations
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
- Ability to build productive internal/external working relationships
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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