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Opening for Advance Quality Engineer.

Keywords / Skills : PPAP, APQP, MSA, SPC, FMEA, Risk Management, Process Capability, Complaint Handling, Supplier assessment & control, Data analysis, Measurement systems, Pro-E, understanding of Design system and ability to read Design prints.

3 - 7 years
Posted: 2019-04-01

Nationality
India
Industry
Hospitals/Healthcare/Diagnostics
Function
IT
Role
Other Software/Hardware/EDP
Education
Bachelor Of Technology (BTech
BE)
Posted On
1st Apr 2019
Job Ref code
GH/PHL/JC//29032019/
/82808
Job Description
  • Primarily responsible for: Risk management, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review,
  • Device Master Record, Quality Training Plan and Technical File.
  • Primary participant in new supplier selection, validation, and contract development. Assists vendors in resolving
  • manufacturing and quality issues as required.
  • Partners with the operations team to develop and maintain a robust internal and external supply chain.
  • Contribution examples include the performance of supplier audits, risk assessment/mitigation, and coaching.
  • Develop procedures for incoming, in-process and final inspections for new product development
  • Assists and mentors the unit quality engineer in the trending and analysis of quality data (e.g. complaints, Tech
  • Support trouble tickets, Pareto charts, scrap, warranty return rate, etc.) and provides guidance to address issues as appropriate.
  • Authors and reviews procedures to ensure GMP and ISO 13485 compliance.
  • Lead product quality related projects. Supports the business in addressing and solving quality problems
  • Conduct internal audits & participate in corporate and FDA audits
  • Support process validation programs for new product development
  • Work with cross-functional/cross –cultural teams to develop regulatory guidelines and procedures
  • Provide inputs for NPDP for adherence to QMS and Good Documentation practices
  • Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product
  • safety and reliability
  • Must have delivered multiple projects in AQE function and understand Risk Management processes in depth.


About Company

GlobalHunt India is a leading executive search & selection firm, in terms of services offered, professional team, mandates handled and Industry specializations across Asia-Pacific, US and Europe markets. Currently we would like to touch base with you regarding an opening with one of our client. Please touch base with us and send across your CV in word format to discuss it further. I am sending you some details for an opening that might help you to give a better perspective about the position as well as the organization. If you have any query; do give me a buzz.
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