Supervisor Complaint Processing
- Heredia
- Permanente
- Tiempo completo
- Provide daily direction to the local team of analysts responsible for processing complaints.
- Have a future-focused perspective to ensure that trends are ahead of trends.
- Managing the application of policies, procedures, and new product launches that impact the complaint processing department.
- Provide support as a complaint processing expert in internal and external audits.
- Ensure that complaint records meet the appropriate requirements and ensure that the equipment is kept up to date with current obligations.
- Lead internal controls to ensure required performance compliance for the team in charge.
- Provide support when required in other functional areas of the PMQA department such as Intake or reporting.
- Performer of quality activities such as CAPAs, internal audits, change control or procedures.
- Ensure the development of its staff in charge through the tools provided by the organization.
- Prepare and submit data related to product complaints.
- Ensure continuous improvement related to error control in data integrity through good documentation practices.
- University degree in technological careers, engineering, or with a scientific approach such as: chemistry, pharmacy, biology, microbiology.
- Advanced knowledge of the English language, at least B2+, C1 (preferred) of the European framework.
- Work experience of at least 3 years in the regulated medical device industry (GMPs) and quality, occupying a position at a technical or professional level.
- At least 1 year in a leadership role (leading professional individuals)
- Experience in project execution
- Technical knowledge in regulations/standards: FDA 21 CFR part 803, 820, EU MDR, ISO 13485:2016 (Preferred)