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Sr. QE (Capitol EE)
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Design
Projektbeschreibung
* Quality Plans (product and supplier)
* QFD's
* Risk Management Plans and Reports
* Risk Assessments including Hazard Analyses and Risk Analyses
* Fault Tree Analysis/FMEA's (Design, Application, and Process)
* Design Verification and Validation strategies and acceptance criteria
* Test method development and validation
* Risk based sampling plans
* First Article Inspection's and Reports
* Process Validations/Capability Analyses
* Post Market Surveillance Reports
1 Ensure completeness of project documentation (e.g., DHF).
2 Collaborate with plant QA on NPD projects, ensuring quality deliverables have been met.
3 Ensure all tasks are conducted in accordance with applicable regulatory standards and standard operating procedures.
4 Other duties as assigned with or without accommodation.
* Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
* Working knowledge of FDA QSR, ISO 13485 and Medical Device Directive in regards to design controls and product realization.
* Ability to apply tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
* Ability to interpret mechanical drawings.To find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
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Einsatzort:
San Jose, California, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Medien/Design