Sound knowledge on New Product Development Process.
Hands on experience of problem solving methodology and root cause analysis.
Good Understanding of Risk Management process.
Sound knowledge of GDP, Inspection, ISO 9001 & ISO 13485.
Good understanding of Supplier Management, SPC, 21 CFR Part 820 and 21 CFR Part 803 (Medical Device reporting).
Demonstrated organizational and written/verbal communication skills.
Demonstrated ability to prioritize tasks in a deadline-driven environment.
Sound knowledge of QC tools.
Good Understanding of root cause analysis.
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports etc.
Support divisional DQA on Design documents review.
Support Supplier Manager.
Support R&D teams on divisional design control.
Develop review matrix for each project and track the progress.
Ensure project management progress is in resonance with design controls.
Weekly updates on each project status and plan.
Conducting knowledge sessions for the team on NPDP topics.
Making central repository of all QE documents and organize weekly update meetings.
Track NC/CAPA, audit observation and complaints.