Ph: 962**-***** Email: email@example.com
I am an accomplished team oriented remediation and quality assurance engineer with 5 years of experience in Manufacturing, DHF Remediation, process validation and Quality & Compliance Management. For past 4 years, I am extensively involved in Hazard Analysis, Risk Management, dFMEA, PFmea, Design verification & validation, Design History Files review, Design Standards review
DHF Remediation, Process Validation, FMEA
ISO 14971, 21 CFR 820 & 13485, IEC 62304, 60601-1
Test Method Validation
Complaints handling & Investigation
Agile, Windchill, Minitab
Design Quality Engineer, Jul 2014 to Current
HCL Technologies, Chennai
Worked on complete Device history files and Design history files.
Worked on medical device projects for medical device players in market and supported them in 510 (K) submission.
Strong Knowledge on design phase reviews and complete documentation for 510 (k) submission.
Reviewed and signed off verification and validation protocols and reports in PLM.
Spearheaded a team of 4 engineers working under DHF Remediation and process validation projects.
Performed Legacy review of process documents to identify gaps in documentation.
Drafting requirements for medical disposables (components / subsystems / system level) and owning Design Input Documents.
Drafting and owning Risk Management Plan, Hazard Analysis, Complaint Code Analysis, Use Error Risk Analysis (Misuse FMEA) and Risk.
Involved in the medical device labelling and packaging material selection projects.
Strong knowledge on complaint handling and complaint analysis.
Interacting with medical team, technical operations, regulatory, quality, etc. for gathering the inputs.
Strong knowledge on design requirement specification, Engineering Drawings, Verification, validation & Testing and Product Validation documents
Participated and implemented tools DOE’s, Risk Management and ensure compliance to CTQ’s and safety requirements.
Engineer- Moulding Division, June 2013 to July 2014
Amul Polycure Industries limited, Chennai.
Overall In charge of Plastic Injection Molding Department.
Coordinated and worked with selection of outside vendors for capabilities not available internally. Responsible for development, troubleshooting and enhancement of multiple existing products to improve performance and customer satisfaction.
Accountable for selection of optimal material to meet customer functional requirements and balances customer and manufacturing requirements to optimize geometry for manufacturability.
Instrumental at Process Optimization, Utilization of man & m/c.
Initiated Vendor visit to improve the Supplier quality & dispatch.
Handling Daily Molding Production Planning & Improvement Activity
Study & Improvement activities carried for New Mould Trial
Maintain All ISO 9001 :2000, ISO 14001, OHSAS 18001 in Plastic Engineering Department
Handling of New Mould trial for its further Approval.
Material Processed like PC, PU, PP, Nylon, PolyAcetol.
Bachelor of engineering, Mechanical in IFET College of engineering affiliated to Anna University, Chennai
Coursework in ANSYS, Product Design, Material Engineering, Lean, Quality and Reliability, Tool and Fixture Design, with extensive work in manufacturing processes
Certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971 from PMP certifications, Chennai.
Date of Birth : 25-11-1991
Father’s Name: Mr.V.Jaghadeesan
Mother’s Name: Mrs.J.Palaniamal
Marital Status: Married
Permanent Address: No.212, velanthottam street, Thiruventhipuram,
I hereby declare that the above-mentioned information and details are true to the best of my knowledge