Advance Quality Engineer

Work Flexibility : Hybrid or Onsite

What will you do :

• Primarily responsible for Risk management and risk assessment as per ISO 14971 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.
• Develop procedures for incoming in-process and final inspections for new product development
• Assists / Leads in the trending and analysis of quality data (e.g. complaints scrap warranty return rate etc.) and provides guidance to address issues as appropriate.
• Authors and reviews procedures to ensure GMP and ISO 13485 compliance and provide inputs for NPDP for adherence to QMS along with good documentation practices
• Lead product quality related projects. Supports the business in addressing and solving quality problems
• Support process validation programs for new product development
• Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability

What you need :

Basic Qualifications :

Preferred Qualifications :

Travel Percentage : 20%

Key Skills

APQP,Quality Assurance,Six Sigma,ISO 9001,PPAP,Minitab,Root cause Analysis,ISO 13485,Quality Systems,Quality Management,As9100,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1