Quality Assurance Manager

hace 4 semanas

Madrid, Madrid, España Abbott Laboratories A tiempo completo
{"title": "Quality Assurance Manager", "content": "About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self, and live a full life.

What You Will Do:

  • Responsibility for compliance with Abbott Commercial Quality System (QS) and local laws and regulations.
  • Ensuring Quality System effectiveness through implementation and maintenance of respective procedures and processes.
  • Assurance that all relevant requirements are met prior to distributing product in the countries/region incl. product labelling with country regulations.
  • Supervision and control of compliance with quality procedures, incl. implementation, training, and documentation.
  • Providing expert quality advice and supports commercial/business processes regarding quality aspects, incl. e.g. launches and/or other commercialization projects/processes.
  • Planning and conducting internal and external audits to verify the effectiveness of the management system.
  • Effectively executes key quality processes e.g., Management Reviews, Supplier/Distributor/Warehouse Control, CAPA, Ad/Promo, Quality Hold, Document Control and Record Keeping according to established and/or newly developed procedures (e.g. OneAbbott) and supports further developments.
  • Performs evaluation, re-evaluation and monitoring of suppliers/distributors/warehouses. Evaluate Third-Party Warehouses and Distributors with respective on-site audits (as appropriate).
  • Support of medical event reporting and field actions in close cooperation with PQA, Customer Service, Regulatory Affairs and Vigilance/MED.
  • Supports local complaint handling/product replacement process and related aspects e.g., with relevant partners/functional ADC units like PQA and represent respectively within the Affiliate Management Team.
  • Initiates, supports, and participates in Quality System improvements and implementation projects.
  • Takes ownership for a QS process and supports the QS Champions Program (e.g., MIMS/ADC Subject Matter Expert/Champion).
  • Travel: Approximately 10-25%

Requirements:

  • Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).
  • Preferably 3-4 years of experience in the Medical Device Industry in the area Quality/Regulatory Affairs or equivalent experience/knowledge of regulatory requirements and applicable quality standards.
  • Solid technical understanding/scientific knowledge of products.
  • Excellent organization skills; project management experience are a plus.
  • Knowledge of PC-based applications, such as Microsoft Office.
  • High Proficiency in English language.

Join a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

"}

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