The candidate will create, execute, and teach advanced design quality practices. The candidate will be
responsible for supporting Business Development & Engineering/R&D via meetings with prospective
customers and developing a technical relationship with other engineers. The candidate will report to the
VP of Quality and must be able to function with little supervision.
Roles and Responsibilities Include:
- Functioning as a subject matter expert for:
o Quality Engineering – Quality by Design (i.e. proactive risk mitigation through HFE
o Design Assurance – Working with NPD Engineers to control product development
through a phase-gate approach.
o Supplier Qualification – Working with NPD team to research and qualify new suppliers.
o 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
- 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, Chemical, Material
Science, Plastics, etc.) (Required).
- A minimum of 3+ years related work experience in the medical device field (Required).
- A working understanding of ISO-13485, ISO-14971, ISO-9001, ISO-17025, GLP, and 21 CFR 820
- The ability to perform statistical analysis using k-factors, PpK, or capability indices as well as
sample plan creation and analysis (Required).
- Six Sigma Green/Black Belt (Preferred).
- Experience working through all aspects of medical device design/development including
o Design verification & validation.
o Process validation.
o Technology transfer.
- An understanding of design for manufacturability and assembly / design for six sigma
- Experience with test method development & validation (e.g. measurement/test system
development, gage R&R, etc.) (Required).
- Experience and understanding of design for plastics injection and the mold fabrication processes
- Experience and understanding of the design for profile extrusion processes.
- An understanding of design of experiments (Required).
- Experience and understanding of lean manufacturing (Required).
contact zara : 9176304295