Engineer Jobs in Chennai

Engineer

Flex

0 to 3 Years

Not disclosed

Expired

Posted: 30 Jun 20

Job Description

The Engineer - GBS Engineering will be based in Chennai .

We Are Looking For Someone Who Demonstrates

Here Is a Glimpse Of What You'll Do

Responsible for coordinating new manufacturing line specification, qualification, validation and ramp to high volume following all cGMP and ISO 13485 protocols and standards.
To work with R&D team, Pilot equipment suppliers & engineering team to validation Pilot production line
Responsible for Pilot line User requirement Specification with edits as Project progresses
Responsible for preparing Qualification & validation documents(DQ,IQ,OQ,PQ,FQ)
Assist with core team for Quality documentation URS, PFMEA, Control Plan, Risk Mitigation Plans
Verify the validation activities as subject matter expert to ensure that processes fully comply with ISO and FDA regulation requirements
Works with manufacturing engineering to address quality issues
Follow up on CAPA, (Corrective Actions Preventive Actions) NCRs (Non-Conformance Report) and ECRs (Engineering Change Requests); participate in root cause analysis

Here Is Some Of What You'll Need (required)

Experience in Medical/EMS / Electronics Products Manufacturing Industry.
Experience in In-process , Supplier Quality and Customer Quality activities
Knowledge and experience in Quality Tools , Problem solving tools , Customer Complaint analysis
Knowledge and experience in preparation of various Quality reports.
Knowledge and experience in preparing the Quality plan for the Reports and other services.
Train new and existing team members on an ongoing basis on relevant tools or topics.
Plan and execute the project / service transition as per time line
Sound knowledge on FMEA and Control Plan and able to work independently in these areas
Knowledge and experience in Lean and Kaizen projects

Here Are a Few Of Our Preferred Experiences

Knowledge of MS office and MS outlook
Knowledge on Medical standards (ISO 13485 , FDA, EU MDR)
Certified ISO 9001: 2008 auditor. TS certification and other certifications an added advantage
Able to prepare FMEA and Control Plans
New Product / Project Management
Knowledge on ERP ( Baan , SAP ) and any one of the PLM software
Good written and oral communication skills

Here are a few examples of what you will get for the great work you provide: