Job Description
Description
Job Description
The Quality Engineer will provide quality engineering leadership and support for manufacturing process development and production of disposable medical catheters. This role works cross-functionally with Manufacturing, R&D, and Regulatory teams to ensure compliance with all applicable regulatory and quality standards.
Key responsibilities include leading process validation activities (IQ, OQ, PQ), supporting test method validation, and ensuring the effectiveness of quality systems across manufacturing operations. The role also supports risk management activities such as pFMEA and control plans, and plays a key role in resolving quality issues related to non-conformances and CAPAs.
Additional responsibilities include supporting sterilization validation, environmental monitoring programs, audit readiness, and ensuring proper documentation and compliance with design and manufacturing records (DHF, DMR, DHR).
This is a highly visible role within a ...
Job Description
The Quality Engineer will provide quality engineering leadership and support for manufacturing process development and production of disposable medical catheters. This role works cross-functionally with Manufacturing, R&D, and Regulatory teams to ensure compliance with all applicable regulatory and quality standards.
Key responsibilities include leading process validation activities (IQ, OQ, PQ), supporting test method validation, and ensuring the effectiveness of quality systems across manufacturing operations. The role also supports risk management activities such as pFMEA and control plans, and plays a key role in resolving quality issues related to non-conformances and CAPAs.
Additional responsibilities include supporting sterilization validation, environmental monitoring programs, audit readiness, and ensuring proper documentation and compliance with design and manufacturing records (DHF, DMR, DHR).
This is a highly visible role within a ...
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