Capa Specialist- Internal Investigations (Process Quality Associate)

• Independent coordination and processing of internal deviations in collaboration with relevant departments and other interfaces.

• Independent monitoring of on-time processing of internal deviations and defined corrective actions (including long-term CAPAs).

• Independent review of 8D reports for consistency, plausibility, adequacy, and clarity, particularly with respect to:

  • Definition of affected products or materials.

  • Root cause analysis.

  • Corrective and preventive actions.

  • Effectiveness verification.

• Advising production regarding required rework or implementation of changes.

• Independent evaluation of blocked stock to determine disposition (e.g., release, rework, scrapping).

• Participation in processing customer complaints.

• Support continuous improvement initiatives (e.g., 5S).

• Perform additional quality assurance tasks in production as assigned (e.g., process monitoring, hygiene checks, sterilization activities, etc.).

• Processing time of internal deviations (critical deviations).

• CAPA (Corrective and Preventive Actions) overdue rate.

• Frequency of recurring errors.

• Very good knowledge of relevant quality management (QM) guidelines.

• Good knowledge of quality management systems.

• Good understanding of production processes and manufacturing methods.

• Strong technical comprehension.

• Good command of English, spoken and written.

• 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.

• Motivation for achievement and innovation.

• Action orientation, conscientiousness, and flexibility.

• Sensitivity and strong interpersonal skills.

• Sociability and team orientation.

• Emotional stability, resilience, and self-confidence.

All your information will be kept confidential according to EEO guidelines.