Job Description
**What will you do:**
+ Primarily responsible for Risk management and risk assessment as per ISO 14971, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File.
+ Primary participant in new supplier selection, validation, and contract development. Assists vendors in resolving manufacturing and quality issues as required.
+ Partners with the operations team to develop and maintain a robust internal and external supply chain.
+ Develop procedures for incoming, in-process and final inspections for new product development
+ Assists/Leads in the trending and analysis of quality data (e.g. complaints, scrap, warranty return rate, etc.) and provides guidance to address issues as appropriate.
+ Authors and reviews procedures to ensure GMP and ISO 13485 compliance and provide inputs for NPDP for adherence to QMS along with good documentation practices
+ Lead product quality related projects...
+ Primarily responsible for Risk management and risk assessment as per ISO 14971, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File.
+ Primary participant in new supplier selection, validation, and contract development. Assists vendors in resolving manufacturing and quality issues as required.
+ Partners with the operations team to develop and maintain a robust internal and external supply chain.
+ Develop procedures for incoming, in-process and final inspections for new product development
+ Assists/Leads in the trending and analysis of quality data (e.g. complaints, scrap, warranty return rate, etc.) and provides guidance to address issues as appropriate.
+ Authors and reviews procedures to ensure GMP and ISO 13485 compliance and provide inputs for NPDP for adherence to QMS along with good documentation practices
+ Lead product quality related projects...
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