Job Profile- Bio Medical Engineer
1. Project Cost Calculation.
2. Collection of necessary information / quotation required for project without sharing name of our company
3. Vendor Analysis and report generation
4. Data collection from Import Export web site by HS code / by product
5. Good interaction with - Data import export agencies
6. Import Export Analysis of Medical Device
7. Plant and Equipment Qualification Documents preparation and review
8. Execution of plant validation and calibration of equipment (Good Knowledge of HVAC and Clean Room Equipment)
9. Validation/Calibration Report Finalization with Validation/calibration agency as per class, particle requirement ( Should be aware of tests mentioned in ISO 14644 )
10. Writing/ Preparation of SOPs of all departments as per regulatory norms with systematic flow process chart and review
11. Writing/ Preparation of Site Master File and Quality Manual of the company as per Medical Device Rule 2017.(Specifically Schedule 4th and Schedule 5th )
12. Preparation and Review of all technical documents and formats.
13. Oversee site (BI Plant) construction as per schedule M and M III (Mentioned under D & C Act 1940, 1945,1946)
14. Vendor communication, Goods vendor Practice, Vendor work plan and execution
15. Site closing report Preparation
16. Sign off on site closing report in win win situation (Helps management to take monitory decision)
Mumbai +2 Nashik, Pune
4 - 10 yrs
