Senior CAPA Specialist mfd Medical Devices
Senior CAPA Specialist mfd Medical Devices
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Job Description
As a (Senior) CAPA Specialist (m/f/d) Medical Devices you will play a critical role in ensuring the effectiveness and compliance of our NC (NonConformance) and CAPA (Corrective and Preventive Action) processes. You will collaborate with crossfunctional teams to drive issue resolution enhance problemsolving methodologies and maintain compliance with global quality and regulatory requirements.
This is initially 24 months fixedterm position.
What You Will Do
Review and approve NCs and CAPAs ensuring completeness accuracy and timely resolution.
Guide and support teams through all stages of the NC/CAPA process facilitating problemsolving techniques such as 5 Whys fishbone diagrams and process mapping.
Act as an eCAPA system superuser and provide training to ensure adherence to CAPA procedures.
Monitor site NC/CAPA KPIs generate reports and support quality and business review forums.
Lead NC/CAPA Review Board meetings ensuring alignment with global requirements and continuous improvement.
Support internal and external audits related to NC/CAPA processes.
Drive collaboration and standardization across global teams to enhance CAPA effectiveness.
Identify process improvements to enhance efficiency and compliance.
What You Need
Required:
BS inEngineering Science or related degree; MS is preferred. OR you have a Technician/Meister degree with minimum 4 years of experience in a quality discipline.
05 years of experience in a regulated environment (Medical Devices Pharmaceuticals or similar). The role level (Specialist or Senior Specialist) will be determined based on experience.
Strong communication skills and the ability to manage multiple priorities effectively.
Your Englishand German language skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office.
Preferred:
Experience with CAPA NC management or quality systems in a regulated industry.
Understanding of ISO 13485 MDSAP and FDA 21 CFR Part 820 quality regulations.
Familiarity with problemsolving methodologies and continuous improvement initiatives.
Strong analytical skills and attention to detail.
Diversity is important to us. We welcome applications from people regardless of their ethnic national or social origin gender disability age or sexual identity.
Additional information
Thanks to our flexible working hours model you will have the opportunity to work partially from the home office. However a regular presence of 34 days a week on site in Freiburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
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Travel Percentage: 10Required Experience:
Unclear Seniority
Employment Type
Full-Time
