Girish Hanchinamani
Quality Leader
- Role
- Director of Quality- Post Market Surveillance at embecta
- Location
- Lexington, MA, US
- LinkedIn followers
- 500 followers
About Girish Hanchinamani
Dynamic 23 years of career reflecting pioneering experience in manufacturing of medical devices and electronics assemblies. Directed cross functional teams in implementing FDA 21 CFR Part 820 regulations and ISO 13845 standard. Managed quality operations for 100+ million-dollar medical device plant. Managed Quality System (QSM) teams including, CAPA (Corrective & Preventive Actions), Customer Complaints, Internal Audits, Supplier Audits, Document Control, Training & Quality Improvement Plan (QIP). Direct experience in interaction, negotiations and inspections by regulatory bodies & by customers (Second- & Third-Party Audits). Experience in Global Sourcing & Contract Manufacturing (CM). Experience in fast paced Medical Start-up for Class device. Adept at managing all aspects as a leader of the group including, budgeting/forecasting, cost center management, hiring, talent development, performance reviews, managing customer escalations and relationships etc. Specialties: Quality Operations, Medical Device Manufacturing (MDM), Quality Systems and Regulations (FDA 21 CFR Part 820 and ISO 13845), Global Sourcing, Contract Manufacturing (CM), Supplier Quality / Supplier Development (SQE/SDE), Electronic documentation (Lotus Notes, NWQS, Matsercontrol, Agile, Windchill), Budget & Forecast, Cost center management, Customer Relations
Experience
Director of Quality- Post Market Surveillance
May 2024 — Present · US
Education
University of Massachusetts Lowell
Masters, Plastics Engineering
1999 — 2001
University of Mysore
BE, Polymer Science
1994 — 1998
Skills
- Global Sourcing
- Spc
- Injection Molding
- Six Sigma Green Belt
- Solidworks
- Fda
- Six Sigma
- Iso 13485
- Plastics
- Quality System
- V&V
- Cross-Functional Team Leadership
- Supplier Quality
- Fmea
- Electronics
- Lean Manufacturing
- Engineering
- Management
- Design of Experiments
- Manufacturing
- Dmaic
- Manufacturing Engineering
- Medical Devices
- Product Development
- Design for Manufacturing
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