Description
As core team member on development projects, perform or contribute to the development of the following:- 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
- 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.
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