Capa Specialist- Internal Investigations (Process Quality Associate)

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Independent coordination and processing of internal deviations in collaboration with relevant departments and other interfaces.
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Independent monitoring of on-time processing of internal deviations and defined corrective actions (including long-term CAPAs).
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Independent review of 8D reports for consistency, plausibility, adequacy, and clarity, particularly with respect to:
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Definition of affected products or materials.
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Root cause analysis.
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Corrective and preventive actions.
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Effectiveness verification.
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Advising production regarding required rework or implementation of changes.
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Independent evaluation of blocked stock to determine disposition (e.g., release, rework, scrapping).
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Participation in processing customer complaints.
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Support continuous improvement initiatives (e.g., 5S).
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Perform additional quality assurance tasks in production as assigned (e.g., process monitoring, hygiene checks, sterilization activities, etc.).
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Processing time of internal deviations (critical deviations).
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CAPA (Corrective and Preventive Actions) overdue rate.
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Frequency of recurring errors.
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Very good knowledge of relevant quality management (QM) guidelines.
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Good knowledge of quality management systems.
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Good understanding of production processes and manufacturing methods.
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Strong technical comprehension.
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Good command of English, spoken and written.
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Good IT user skills (e.g., MES/SAP, MS Office).

• Knowledge acquired through at least a 3-year technical education program, supplemented by a minimum of 4 years of experience in operational quality assurance.

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Motivation for achievement and innovation.
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Action orientation, conscientiousness, and flexibility.
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Sensitivity and strong interpersonal skills.
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Sociability and team orientation.
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Emotional stability, resilience, and self-confidence.
All your information will be kept confidential according to EEO guidelines.