Job Description

• Bangalore, KA

Essential Functions

• Create queries or data gathering tools to track key quality indicators using PowerBI or other application specific tools (Azure, ServiceNow).
• Collaborate with Subject Matter Experts (SMEs) and associated departments in support of process improvement/enhancement activities.
• Monitor applicable quality systems through trending analysis, compiling metrics and developing reports on a regular basis in support of improvement initiatives.
• Participate in and provide guidance to change management and product development.
• Plan and execute internal audits under ISO 13485, ISO 9001, ISO 27001, 21 CFR 820, IVDR, etc.
• All other duties and responsibilities as assigned. 

Skills needed to be successful

• Analytical skills that include trending and evaluation of data with the ability to identify potential process and product improvements.
• Organizational, planning, project management and process improvement skills.
• Detailed knowledge of industry regulations and standards
• Experience with auditing, quality tools and process improvement techniques. ·
• Excellent oral and written communication skills.
• Excellent problem-solving skills
• Detail Oriented

Required Experience & Education 

• Bachelor’s degree or equivalent
• Proficiency with Microsoft Office
• Experience with Microsoft Azure
• 5 years quality assurance experience in a regulated industry (ISO 13485, ISO 9001, ISO 27001)
• Experience with Healthcare Software 

Preferred Experience & Education

•  Proficiency with writing queries in Microsoft Azure, ServiceNow, and/or other applications
• 10 years’ experience in Quality Assurance within the medical device field