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:

• Bachelors in mechanical or biomedical or Biotech Engineering.

  
  
  

• Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)

  
  
  

• Minimum 2 to 6 years of relevant work experience.

  
  
  

• Experience in the NPD process and various phases of new product development.

  
  
  

• Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.

  
  
  

Preferred Qualifications:

• Good analytical and problem-solving skills.

  
  
  

• Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.

  
  
  

• Expert-level knowledge of current industry standards for New Product Development and risk management practices

  
  
  

• Excellent communication and presentation skills

  
  
  

• Must have delivered multiple projects in AQE function and understand Risk Management processes in depth.