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Roles and Responsibilities Include:
· Quality Engineering – Quality by Design (i.e. proactive risk mitigation through HFE analysis).
· Design Assurance – Working with NPD Engineers to control product development through a phase-gate approach.
· Supplier Qualification – Working with NPD team to research and qualify new suppliers.
· Risk Management – Leading NPD team(s) in creation of dFMEA, pFMEA, and RMR compliant with ISO-14971.
- Maintaining and improving the Quality Management System.
-CAPA ownership and/or support.
-Interacting effectively with customers, suppliers, and internal resources.
-Managing projects and/or providing project support from the Quality function.
- Facilitating the identification of project risks, developing mitigation actions, and managing mitigation plan(s).
- Performing root cause analysis and corrective actions.
- Effectively employing problem solving tools/methodology.
- Other responsibilities as assigned.
A Bachelor’s degree in related engineering or technical field (e.g Mechanical).
- A minimum of 5 years work experience in this field.
· Design verification & validation.
· Process validation.
· Technology transfer
- Experience with test method development & validation (e.g. measurement/test system development, gage R&R, etc.) (Required).
- Experience and understanding of the design for profile extrusion processes.
- An understanding of design of experiments (Required).
- Experience and understanding of lean manufacturing (Required).
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