Beschreibung
Task:- Utilize Quality Engineering tools for the effective and efficient development and maintenance of raw material and finished goods suppliers.
- Utilize quality engineering principles and problem solving skills to develop and optimize supplier performance that are aligned with the overall Quality and Business vision.
- Ensure effective risk management to prevent unanticipated failure modes and ensure capability.
- Partner with Engineering, Procurement and Suppliers to ensure the application of process validation, process control, and process risk management
- Partner with Engineering, Procurement and Suppliers in the investigation/correction of process failures.
- Implement and monitor process capability for continuous improvement.
- Ensure effective supplier initiated base business change control.
- Proactively communicate with DQE any base business changes in design or changes in process that could affect product design.
- Develop systems to ensure quality of purchased raw materials and finished foods.
- Ensure supplier performance is monitored, reviewed and addressed as needed. Provide leading metrics to QA/RA Business Unit Directors.
- Utilize technical skills specific to assigned commodities (ex., sterilization, plastics, chemicals, etc.) to ensure adequate quality and control plans based on critical to quality requirements.
Requirements (Must have):
Experienced (preferred 3 years of experience) in the fields of
- GMP
- PFMEA
- Six-Sigma
- FDA QSR
- ISO 13485/ISO 14971
Beginn: 01.12.2014
Dauer: 01.05.2015
Branche: Medizin/Healthcare