Engineer Quality Process Onsite
Engineer Quality Process Onsite
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Job Description
Stryker is hiring an Engineer Quality Process in Chandler Arizona to support Strykers Sustainability Solutions (SSS)! In this role you will be responsible for analyzing and resolving production issues by collaborating closely with engineering and material procurement teams. You will also monitor process data analyze trends evaluate financial results and incorporate customer feedback to drive continuous improvement.
What you will do:
Conduct the implementation and maintenance of systems ensuring global regulatory compliance.
Perform robust root cause analysis of production issues implement appropriate containment and drive corrective action.
Monitor / analyze production performance trends for key quality metrics and establish appropriate control measures.
Drive detection and prevention of nonconformances to improve business results through reductions in s and rework costs in addition to assurance of a positive customer experience.
Evaluate and improve quality inspection methods and fixtures to improve reliability and repeatability of incoming inprocess and final QC.
Analyze the risk associated with nonconforming inspection equipment and take action on affected products.
Identify and lead implementation of process / procedure / system improvements. For example component qualification process skip lot process supplier change process etc.
Partner with Operations and Division engineering to develop solutions to nonconformances.
Provide support during internal and external audits.
Oversee postmarket reporting including Medical Device Reporting (MDR) and Medical Device Vigilance (MDV).
Maintain uptodate knowledge of global regulatory requirements for adverse event reporting.
What you will need
Required:
B.S. in engineering or related discipline. Biomedical strongly preferred.
0 experience in Quality Assurance or engineering.
Preferred:
Ability to train Technical Service and Support teams on compliance with postmarket surveillance requirements.
Ability to collaborate with key partners to ensure global policy adherence and process improvements.
Provide strategic planning and tactical direction to meet quality objectives and predefined metrics.
Employment Type
Full-Time
