Capa Specialist- Internal Investigations (Process Quality Associate)

Capa Specialist- Internal Investigations (Process Quality Associate)

Full-time

Job Description

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.

Qualifications

• 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).

• Additional Information

• 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.

• Benefits with us

• Food & drinks

• We have a self -serve break area with drinks, snacks & light finger food for purchase.

• Learning & development

• According to the job and position, we make sure our employees get regular trainings and coaching to unleash their possibilities. We offer education reimbursement.

• Healthcare & pension

• Your health and well-being is important to us. We offer the following benefits: 401 K Match up to 4.5%, Medical/ RX/ Dental/ Vision, Life LTD & STD, Optional Accidental / Critical Care and Illness & Hospitalization, Optional Spouse & Child

• Working environment

• Creating a great place to work is essential for us, so we live up to our values teamwork, responsibility, integrity, bold innovation and excellence (TRIBE).

• Wellness & other incentives

• Referral program, Gym incentive, Pacer step challenge