ESSENTIAL FUNCTIONS:
Practices and mentors in the use of company concepts, policies and procedures, familiar with and follows standard practices.
Applies functional expertise routinely on the job.
Receives general direction and exercises considerable discretion as to work details.
Contributes to the definition and timely achievement of overall project goals.
Participates in efforts to define new components, products or processes.
Identifies and implements improvements to work processes.
Designs, plans and executes project related tasks.
Consults and provides training for areas of statistical quality control such as SPC, Process capability, DOE, etc.
Assures experimental quality through sound, independent, experimental design.
Participates on cross functional technical teams.
Provides technical direction and feedback to others.
Participates in project planning, process updates and contributes to experimental design.
Monitors work to ensure quality, and continuously promote Quality First Time.
Skills :
Knowledge, Skills and Abilities:
Demonstrates success in technical proficiency, creativity, collaboration with others and independent thought.
Expert knowledge of applicable regulations and standards, including FDA QSR Part 820, ISO13485
Expert knowledge of Quality engineering principles and concepts.
Experience in medical device, including software, reagents, and assay development, design control process.
Need software and medical device development understanding, partnered with Design Control regulations
Education
Formal Training/Education: BS in a directly related discipline. Advanced studies or training.
Experience:Typically requires a minimum of 8 years of related experience
Note :
Ensure all project documentation, review document,
Digital pathology, medical/ biomedical , bio chemistry background
Software Development environment in In vitro diagnostic device (IVD)
5-8 years
Preferred:-
R&D related IVD
similar experience in same domain
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