Advance Quality Engineer

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.