Arok*******

Medical Device Quality Assurance & Regulatory Affairs Engineer

  • India
  • Graduation: Bachelor of Engineering in Mechanical

  • Hourly / Daily / Monthly Rates: 8 / hour 1000 / daily 30000 / monthly

  • Languages: English(Full Professional)

  • Last Update: 08.10.2019 at 05:13

Availability
Available
Country
India

Skills

Organization Profile: HCL Technologies, Chennai.
Department: Engineering Research and Development
Designation: Associate Quality Engineer
Experience: December 2018 to till date
Customer: Baxter
Baxter, a leading Global pioneer in Health Care products, devices, solutions of Advanced Surgery, Renal, Nutrition, Medication Delivery saving and sustaining more than 85 years.
Projects:
 Baxter MDR Design and Construction
 Baxter MDR Specialty
Roles and Key Responsibilities Area:
 Complied with U.S. Food and Drug Administration (FDA) & European Union Medical Device Regulations (MDR) 2017/745 and Medical Device Directives (MDD) 93/42 EEC.
 Subject Matter Expert (SME) of MDR Specialty Group Global Pathogen Safety and Sterility Assurance.
 Defect Prevention Analyst and Change Controller of Project Deliverables.
 Attained Project Six Sigma Green Belt.
 Hands on Experience of performing Gap Analysis & DHF Remediation of EU MDD and MDR.
 Extensive Experience in Product Development Life Cycle, Design Inputs & Outputs, Verification, Validations, RACT, Risk assessments and Mitigations with FMEA.
 Comprehensive knowledge in Technical Writing, Regulatory Affairs and Rationale for Product Applicability.
 Familiar with understanding of Classification of Medical Devices as Class I, IIa, IIb & III.
 Updating Product Clinical Evaluation Report, Technical Dossier, PMS and Design History Files.
 Well-Versed experience with Advanced Surgery products like Implants, Haemostasis Sealants and Anastomotic Instruments.
 Specialized in Animal Origin Medical Products with respective to animal derivatives sourcing, handling and utilizing techniques according to EU Regulation Commission No.722/2012.
 Validation of GPS incorporated TSE/BSE Risk Management.
 Proficient in Medical Products Sterilization process and various test methods involved as Bio-Burden Test, Bacterial Endotoxin Test (LAL).
 Validation of Sterile Barrier and Packaging System test method involved as Container Closure Integrity, Dye Penetration test, Seal Peel strength.
 Knowledge in Medical Products Biocompatibility and test methods involved as Cytotoxicity, Sensitization, Irritation, Genotoxicity and Hemocompatibility.
 Good exposure in GPS, SA, Biocompatibility and Regulatory standards like ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 11607, ISO 11737, ISO 10993, ISO 13485 and MQMS ISO 14971.
 Knowledge in Renal Disposables, Haemodialysis, Catheters, Priming solution priming solution and Medication Delivery Products like Irrigation Solutions.
 Technical Guidance and support to team members.
 Creating Deliverable’s awareness to team members by conducting DPA Meeting.
 Handling weekly status meeting and time plan to ensure OTD.
 Interaction with Onsite PDO and Client for project alignment.
Organization Profile: CY Myutec Anand, Chennai.
Department: Engineering Research and Development, Quality Assurance
Designation: Graduate Engineer Trainee
Experience: March 2016 to December 2018
CY Myutec-Chang Yun Korea Incorporated with Anand Automotive Systems India. Leading Synchronizer Ring Manufacturers in India and Supplies to Hyundai Motors India, Mahindra, ACYM.
Roles and Key Responsibilities Area:
• Prepare Tool Drawings for New Products.
• Trial and developing of New Products.
• Prepare Gauge Drawing For New and Existing Products.
• Feasibility study, FMEA for New products.
• Part of IATF 16949:2016 Internal Auditor.
• APQP prepare and project achieve SOP through FTT within timeline.
• PPAP approval from Customer for NPD and Regular parts.
• Creating Product specifications in International Material Data System (IMDS).
• Process planning and Process documents preparation.
• Prepare Vendor drawings, Process Control plan, SOP, Work Instruction.
• Develop new products and submit ISIR to customers.
• Layout preparation for process and machines.
• ERP process knowledge for material movement traceability of product documents.
• New Machine Installation & Commissioning.
• Tools procurement for process.
• Coordination with Supplier for 4M change and improvement.
• Develop the peoples with technical training.
• Yield improvement initiatives & improvement in process.
• Implement cost reduction & cycle time improvement projects.
• Incoming Inspection of Tools like Die, Punch & Collet.
• Incoming Inspection of Raw Materials like Pipe, Carbon Sheet & Spares.
• Trial Validation of Incoming Materials.
• Supplier monitoring control and supplier Evaluation Technique, Supplier Audit.
• Carryout Root cause analysis and work on NC/CAPA resolution.
Software Skills
• Solidworks
• DraftSight
• Siemens Team Center Unified (TCU)
• Trackwise 8(CCM)
• Trackwise 9(SQLM)
• ERP System
Training & Development:
• Six Sigma Green Belt - HCL
• Solidworks - Navil Groups
• GD & T - CYMyutec
• IATF 16949:2016 Internal Auditor training - CYMyutec
• FMEA, APQP, PPAP Training- Anand group


Refrences

Organization Profile: CY Myutec Anand, Chennai.
Department: Engineering Research and Development, Quality Assurance
Designation: Graduate Engineer Trainee
Experience: March 2016 to December 2018
CY Myutec-Chang Yun Korea Incorporated with Anand Automotive Systems India. Leading Synchronizer Ring Manufacturers in India and Supplies to Hyundai Motors India, Mahindra, ACYM.
Roles and Key Responsibilities Area:
• Prepare Tool Drawings for New Products.
• Trial and developing of New Products.
• Prepare Gauge Drawing For New and Existing Products.
• Feasibility study, FMEA for New products.
• Part of IATF 16949:2016 Internal Auditor.
• APQP prepare and project achieve SOP through FTT within timeline.
• PPAP approval from Customer for NPD and Regular parts.
• Creating Product specifications in International Material Data System (IMDS).
• Process planning and Process documents preparation.
• Prepare Vendor drawings, Process Control plan, SOP, Work Instruction.
• Develop new products and submit ISIR to customers.
• Layout preparation for process and machines.
• ERP process knowledge for material movement traceability of product documents.
• New Machine Installation

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