- Assist in the effective transition from product design to production. Review manufacturing and quality processes for improvement and risk.
- Assist in after-market monitoring activities, such as analysis of servicing data, customer complaint processing and medical event reporting.
- Participate in implementation of appropriate corrective action and preventative action (CAPA) for internal and external findings.
- Work with suppliers on quality improvement projects through use of corrective actions.
- Occasional domestic and international travel required (~5%).
- Introduction and monitoring of lean manufacturing initiatives (5S, line optimization, FMEA, etc)
- Participate in internal and external audits for domestic and international suppliers which may include new supplier approval.
- Drive effective transition from product design to production.
- Lead the after-market monitoring activities, such as analysis of servicing data, customer complaint processing and medical event reporting.
- Perform robust root cause analysis of non-conforming products, implementation of appropriate containment, and drive corrective actions.
- Work with Strategic Sourcing and Purchasing as a Supplier Quality resource.
- Coordinate with supply chain teams to drive collaboration and communication for issue resolution with suppliers.
- Identify and lead implementation of process / procedure / system improvements. For example, component qualification process, skip lot process, supplier change process, etc.
- Monitor / analyze production performance trends for key quality metrics and establish appropriate control measures.
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Quality Engineer - Dallas, United States - Eliassen Group
Description
Our Medical Device client is in need of a Quality Engineer that can work onsite in the Greater Dallas area.
Job Description:
Quality Engineer