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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.
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