Process Associate Jobs in Pune - IZiel Healthcare

PROCESS ENGINEER : JOB DESCRIPTION

• Engineers are the key to success in our organization. We value our engineers and their skills in furthering the cause of helping lives. 
• This opportunity is in the IZiel Healthcare division. IZiel group is in the business of engineering design and analysis, resource placement, real estate development and healthcare services.
• We work with global automotive, engineering, oil and gas and medical device manufacturing clients. Thorough leadership, robust work planning methodology and exceptional customer service are the key enablers of our success.
  

 POSITION DESCRIPTION:

• Provide engineering leadership for engineering design, equipment development, assembly methods and process validation of products. 
• Collaborate on project teams to remediate products for high profile medical device companies with FDA and other regulatory non-compliance issues.
• Develop high quality, high reliability and life impacting implantable products.
• The engineer will work with a US based company to develop engineering products, processes and their associated documentation.

POSITION RESPONSIBILITIES:

• Participate on projects to develop assembly methods, tooling, equipment and processes for current products with emphasis on following quality systems and rigorous documentation to help companies with regulatory non-compliance issues.
  
•  Partner with a Global team lead to collaborate and execute the project with an on-shore/off-shore model.
  
• Developing Validation plan and Validation summary report, review relevant documents like test plan, requirement traceability matrix, IQ, OQ, PQ, URS, Initial Risk Assessment, Test Method Validation, FAT, SAT etc.
  
• Provide input in planning for projects, write technical computer system validation protocols, adhering to company procedures and regulatory expectations.
  
• Create equipment specifications and IQ plans and reports to support equipment installation and qualification process.
  
• Utilize statistics to analyze data, characterize process and perform process validation activities with support from Global team.
  
• Create quality system procedures and work with documentation control systems to create, manage and store documents
  
• Train and teach on concepts related to six sigma and lean manufacturing.
  
• Complete on time project updates, project hours, development plans, peer/self-assessments, and successful completion of all training requirements.
  

• Graduation in engineering
  
• Technical writing, English communication and teamwork.