Beschreibung
* 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.
Education and/or Experience
At a minimum, a BA/BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science.
Business Degree is desirable.
Certifications, Licenses, Registrations:
Certified Quality Engineer (ASQ or equivalent); preferred.
Green Belt or Black Belt certification from a recognized program
Other Skills and Abilities: Demonstrated knowledge and application of QSR, MDD 93/42/EEC, ISO9001, ISO13485, 14971 and other international standards. Geometric Dimensioning and Tolerancing. Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Project). Effective oral & written communication skills. Effective technical writing. Strong influencing skills Sense of urgency, intellectual curiosity, prudent risk-taking. Medical Device Experiences! Minitab, Visio Languages: Fluent German + English (Spoken + written), preferably fluent French
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