Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Provide support to the global team for processing complaints and inquiries from internal and external customers about medical devices and complaints such as sales agents, sales representatives, manufacturing, commercial, hospital or medical sites, in addition to leading the team of analysts, ensuring compliance with regulatory requirements in the process as well as adequate team performance. In addition, it must guarantee compliance with corporate procedures as well as product quality, customer satisfaction in addition to maintaining the quality system, while ensuring the profitability of the same process.

QUALIFICATIONS

• 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.
• Work experience of at least 1 year supervising staff Experience in project execution
• Technical knowledge in regulations/standards: FDA 21 CFR part 803, 820, EU MDR, ISO 13485:2016 (Preferred)
  Additional Information
  AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
  US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
  US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
  https://www.abbvie.com/join-us/reasonable-accommodations.htm

• 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.