Support the global team responsible for processing complaints and inquiries from internal and external customers regarding medical devices and related complaints, such as those from sales agents, sales representatives, manufacturing sites, commercial teams, hospitals, or physicians. Additionally, provide leadership to the analyst team to ensure compliance with regulatory requirements throughout the process as well as effective team performance. Furthermore, the role includes ensuring compliance with corporate procedures, product quality, customer satisfaction, and maintaining the quality system while also overseeing the profitability of the process. MAJOR RESPONSIBILITIES Provide daily direction to the local team of analysts responsible for processing complaints. Maintain a forward-looking perspective to anticipate trends. Manage the implementation 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 complaint records meet corresponding requirements and that the team stays up-to-date with current obligations. Lead internal controls to ensure required performance compliance for the team. Provide support as needed in other functional areas of PMQA, such as Intake or reporting. Act as executor of quality activities such as CAPAs (Corrective and Preventive Actions), internal audits, change controls, or procedures. Ensure the development of direct reports 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.
A university bachelor's degree in technological, engineering, or scientific fields such as chemistry, pharmacy, biology, or microbiology. Advanced knowledge of English, at least B2 level according to the European framework. At least 3 years of work experience in a regulated medical device industry (GMPs) and quality, holding a technical or professional position. At least 1 year of experience supervising staff. Experience in project execution. Technical knowledge of regulations/standards: FDA 21 CFR part 803, 820, EU MDR, ISO 13485:2016 (preferred)
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