The Engineer, Quality Operations is responsible to ensure adoption, compliance and control of a variety of analytical functions that occur in the QC department supporting validation, testing, reporting of in-process, pre and post sterile release, and environmental monitoring samples
Job Summary
The Engineer, Quality Operations is responsible to ensure adoption, compliance and control of a variety of analytical functions that occur in the QC department supporting validation, testing, reporting of in-process, pre and post sterile release, and environmental monitoring samples.
This role also ensures activities occur in an efficient and cGMP compliant manner.
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform.
Matching Summary
The Engineer, Quality Operations is responsible to ensure adoption, compliance and control of a variety of analytical functions that occur in the QC department supporting validation, testing, reporting of in-process, pre and post sterile release, and environmental monitoring samples.
Skills & Requirements
Must-have
cGMP compliant manner
lot qualification testing
in-process quality assurance testing
failure investigation
NCMR
deviation
CAPA
Master Control system
Nice-to-have
exceed customer expectations
continuous improvement
enhance quality system processes
auditor training certification
Key Requirements
Bachelor's degree
2 to 4 years of experience
medical device industry experience
Fluent in English and Malay
Working knowledge of ISO13485
Proficient in Word, Excel, Outlook and Power Point