Staff Quality Assurance Specialist
vor 2 Wochen
The Staff Quality Assurance Specialist will play a critical role in ensuring compliance with regulatory requirements and internal quality standards. This position involves managing the Corrective and Preventive Action (CAPA) process, investigating non-conformances, identifying root causes, and implementing effective corrective and preventive actions.
Main Responsibilities:
- Manage the CAPA process, ensuring timely and effective resolution of issues.
- Conduct thorough investigations of complex non-conformances and deviations.
- Develop and implement corrective and preventive action plans.
- Monitor the effectiveness of CAPA actions and make necessary adjustments.
- Collaborate with cross-functional teams to ensure CAPA actions are integrated into relevant processes.
- Maintain accurate and detailed documentation of CAPA activities.
- Prepare and present CAPA reports to management and regulatory bodies.
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:
As a member of the Abbott team, you will have access to career development opportunities, a dynamic and motivated work environment, and competitive compensation and benefits.
Abbott is a leading manufacturer of medical devices and a Fortune 500 company. We are committed to delivering innovative solutions that improve people's lives.
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