Staff CAPA Specialist

vor 1 Monat


Zürich, Zürich, Schweiz Abbott Vollzeit

Abbott Laboratories is a leading medical device company with a strong presence in the global market. We are seeking a highly skilled Staff CAPA Specialist to join our team in Zurich.

The successful candidate will be responsible for managing the Corrective and Preventive Action (CAPA) process to ensure compliance with regulatory requirements and internal quality standards. This role involves investigating non-conformances, identifying root causes, and implementing effective corrective and preventive actions.

Key Responsibilities:

  • Manage the CAPA process of multiple CAPAs from initiation to closure, ensuring timely and effective resolution of issues with minimal oversight and direct others.
  • Conduct thorough investigations of complex non-conformances and deviations to identify root causes and develop strategy with appropriate business acumen.
  • Develop and implement corrective and preventive action plans to address identified issues.
  • Monitor the effectiveness of CAPA actions and make necessary adjustments.
  • Collaborate with cross-functional teams and multiple sites to ensure CAPA actions are integrated into relevant processes.
  • Maintain excellent accurate and detailed documentation of CAPA activities.
  • Prepare and present CAPA reports to management and regulatory bodies as required.
  • Stay updated on industry regulations and best practices related to CAPA.

Qualifications:

  • Master's degree in a related field (e.g., Quality Assurance, Engineering, Life Sciences).
  • Minimum of 9 years of experience in CAPA management or a related quality assurance role.
  • Strong understanding of regulatory requirements (e.g., FDA, ISO) and quality management systems.
  • Excellent problem-solving and analytical skills.
  • Strong communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Proficiency in using quality management software and tools.
  • Fluency in English and German are required.

Working at Abbott:

At Abbott, you can do work that matters and help people to live a healthier and fuller life, grow your career, and learn, be your true self. You will have access to:

  • Career development with an international company where you can grow.
  • A workplace in a fortune 500 company and the world's leading manufacturer of medical devices.
  • A challenging position in a crisis-independent industry.
  • To become part of a dynamic, highly educated, highly skilled, and motivated team.
  • Multi-national environment, where we foster the development of our talents within the enterprise.
  • Competitive compensations and benefits.
  • A workplace in the heart of Zurich.

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