SQA Engineer

Key Responsibilities:

• Define implement and maintain SQA processes including SEPG/PEG and QMS templates.
  
• Build and improve processes aligned with international standards and business needs.
  
• Ensure compliance with ISO 13485 or ISO 62304 standards.
  
• Work within the Medical Device Software Development Industry or Medical Device GMP.
  
• Understand and apply FDA regulations for medical devices or medical device software.
  
• Manage customer complaints and lead customer satisfaction programs.
  
• Assess risks and determine safety classifications for medical devices and software.
  
• Communicate effectively with stakeholders and manage projects efficiently.
  
• Utilize advanced MS Office applications (Word Excel PowerPoint Microsoft Forms etc.).
  
• Apply knowledge of SDLC and quality tools to ensure product quality.
  

Requirements

Required Qualifications:

• Bachelor s or master s degree in a relevant field.
  
• 24 years of experience in SQA process definition QMS and related areas.
  
• Proficiency in building and improving QMS processes.
  
• Knowledge of ISO 13485 or ISO 62304 standards.
  
• Experience in the Medical Device Software Development Industry or Medical Device GMP.
  
• Familiarity with FDA regulations for medical devices or software.
  
• Strong communication and management skills.
  
• Advanced skills in MS Office applications.
  
• Understanding of SDLC and quality tools
  

Desired Skills:

• Ability to handle customer complaints and manage customer satisfaction programs.
  
• Competence in assessing risks and determining safety classifications.
  
• Excellent problemsolving and analytical skills.
  
• Team player with a proactive approach
  

Benefits

• Health Insurance: Ensure peace of mind with our comprehensive health insurance coverage offering you and your family access to highquality healthcare whenever necessary.
  
• Provident Fund Contribution: Our company provides a provident fund policy with contributions from both the employer and employee. This collaborative effort actively builds your retirement savings establishing a robust financial foundation for your future.
  
• Hybrid Work Mode and Flexible Working Hours: Embrace flexibility through our hybrid work mode allowing you to work remotely for two days from home and spend three days in the office. Take charge of your schedule with our flexible working hours policy empowering you to manage personal appointments and commitments effectively.
  
• Open Fridge Policy: Foster a positive atmosphere in our office with an open fridge policy. Enjoy a diverse selection of beverages and snacks freely available to all employees keeping you refreshed throughout the day.
  
• International Expert Team: Collaborate with a diverse team of international experts to broaden your professional horizons. Learn and work alongside professionals from different backgrounds fostering personal and career growth.