Associate Lead Engineer

Summary

Quality Professional - Medical Devices as per ISO 13485, ISO 9001 and EU MDR 2017/745.
B-Tech (Mechanical Engineer) with more than 06 Years of prosperous & qualitative experience. A professional, in quest of Relationship with growth-oriented Organization as well as Personal and Professional enrichment.
I have a proven track record to deliver business critical solutions that meet our internal and external customer needs while working in a matrix organization. I am a self-motivated individual that drives for continuous improvement, cost reduction and simplified processes that improve productivity without compromising quality or patient safety.
My areas of expertise include the following:
Project Management
Design Excellence & product development
Supply Chain
Equipment/Process Validation
Lean/Six Sigma Technique
QA/QE/QMS.
Risk Assessment.
Verification & validation (HVAC, Sterilization Chamber)
I am interested in new challenges to use my technical skills & experience in a different capacity.
Proficient in ensuring timely completion of Document review, Issuance and Documentation within a Quality System which requires monitoring of work as such Change control, Risk Assessment for new product etc. to ensure quality standard are met.
Support Manufacturing & Operations for product industrialization. My professional background with different FDA classification of product manufacturing industries has taught me to effectively work on new campaigns.

Expectations

I would like to continue my professional career with a company where there is a need to constantly be learning & seeking a challenging technical role where my performance will meet to companys goals.
As a mechanical engineer, I am perfect in Engineering principles, applied tools (Six Sigma) and practices, mechanical Medical system designing and testing. In addition, I have excellent knowledge of CAD, CATIA.
I look forward to discussing your objectives and how we can work together to accomplish them.

Employment Preferences

Expected Base Salary

*,*00,000 INR / year

Academic Degree

Experience

Skills

• Quality Assurance
• QMS
• Regulatory Compliance
• Product Complaint Investigator
• CAPA
• Change Control Management
• Risk Management
• ISO 13485
• ISO 14971
• EU MDR 2017
• Validation
• HVAC Validation
• Sterilization Qualification
• Equipment Qualification
• Test Method Validation
• Clinical Evaluation
• Post Markrt Evaluation. FMEA