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About the Role
Sr. Supplier Quality Engineer
Newark, DE, United States
The Senior Supplier Quality Engineer is responsible for supporting the Supplier Quality organization by overseeing components, materials, and services provided by suppliers. This role ensures that suppliers meet all regulatory and quality requirements, collaborates with internal teams, and drives continuous improvement in supplier performance.
**Knowledge**
+ Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001
+ Quality System Regulation and risk management
+ Validations (IQ, OQ, PQ) and root cause analysis (CAPA process)
+ Project management techniques
+ Measurement system analysis (GR&R, AAA)
+ Statistical Process Controls (SPC) and statistical sampling
+ PPAP (Production Part Approval Process) knowledge (desirable)
+ Familiarity with applicable regulations (FDA, Canada, Brazil, Japan...
Newark, DE, United States
The Senior Supplier Quality Engineer is responsible for supporting the Supplier Quality organization by overseeing components, materials, and services provided by suppliers. This role ensures that suppliers meet all regulatory and quality requirements, collaborates with internal teams, and drives continuous improvement in supplier performance.
**Knowledge**
+ Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001
+ Quality System Regulation and risk management
+ Validations (IQ, OQ, PQ) and root cause analysis (CAPA process)
+ Project management techniques
+ Measurement system analysis (GR&R, AAA)
+ Statistical Process Controls (SPC) and statistical sampling
+ PPAP (Production Part Approval Process) knowledge (desirable)
+ Familiarity with applicable regulations (FDA, Canada, Brazil, Japan...
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