**Company Description**
Provide support to the global team in processing complaints and inquiries from internal and external customers regarding medical devices and complaints, such as sales agents, sales representatives, manufacturing sites, commercial, hospitals, or healthcare professionals.
Additionally, oversee the team of analysts, ensuring compliance with regulatory requirements in the process, as well as effective team performance.
Furthermore, ensure compliance with corporate procedures, product quality, customer satisfaction, and maintain the quality system, while also ensuring the profitability of the process.
**Major Responsibilities**
- Provide daily direction to the local team of analysts responsible for processing complaints.
Take a forward-looking perspective to ensure trends are anticipated.
- Manage the implementation of policies, procedures, and new product launches that impact the complaints processing department.
Provide support as a complaints processing expert in internal and external audits.
- Ensure that complaint records comply with corresponding requirements and ensure the team stays up to date on current obligations.
- Lead internal controls to ensure compliance with required performance for the team in charge.
- Provide support as required in other functional areas of the PMQA department, such as Intake or reporting.
- Provide support as required in other functional areas of the PMQA department, such as Intake or reporting.
- Execute quality activities such as CAPAs, internal audits, change control, or procedures.
- Ensure the development of their personnel in charge through tools provided by the organization.
Prepare and present data related to product complaints.Ensure continuous improvement related to error control in data integrity through good documentation practices.
**Qualifications**
- Bachelor's degree in technological fields, engineering, or with a scientific focus such as chemistry, pharmacy, biology, microbiology.
- Advanced knowledge of the English language.
**Skills**
- Talent management
- Decision-making
- Problem-solving
- Negotiation
- Communication Technical knowledge in regulations/standards: FDA 21 CFR part 803, 820, EU MDR, ISO 13485:2016 (Preferable)
**Additional Information