Job Title
Project Manager
Relevant Experience
in Yrs)
10+ years
Must Have Technical / Functional Skills
- Project Management Professional (PMP) certification is required.
- Must possess knowledge of theoretical and practical fundamentals and experimental engineering techniques.
- Hands on experience working on catheters such STSF, Qdot and Helix catheters.
- Subject Matter Expert (SME) for GSL equipment
- Knowledge on Quality Management and its tools & techniques.
- Knowledge about FDA, ISO 13485, and compliance regulations
- Knowledge on Medical Device Regulatory Standards, MDD and MDR
- Knowledge on NC, CAPA, Audit processes.
- Knowledge in Statistic, Risk Management and Design control.
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