Associate Lead Engineer
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:
Design Excellence & product development
Lean/Six Sigma Technique
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.
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.
Expected Base Salary
*,*00,000 INR / year
Total Professional Experience
- Quality Assurance
- Regulatory Compliance
- Product Complaint Investigator
- Change Control Management
- Risk Management
- ISO 13485
- ISO 14971
- EU MDR 2017
- HVAC Validation
- Sterilization Qualification
- Equipment Qualification
- Test Method Validation
- Clinical Evaluation
- Post Markrt Evaluation. FMEA
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