Position:

Job Description:

* Detailed Description of the Job Profile (Role and Responsibility)

• Performing quality audits as per CMMI / ISO 13485 / ISO 62304 / IEC 14971
• Understanding of software lifecycle
• Medical QMS with regulatory requirements knowledge
• Guiding and facilitating projects for effective process & metrics implementation
• Work product reviews for quality and process
• Writing, updating and implementation of quality management system
• Conducting trainings
• Prepare & Present Management Reviews
• Defining processes and conduct Quality Management System related activities
• Review documents (such as proposals / SoWs /

Project plans) to ensure the quality

• Take other global initiatives such as external audits, Customer surveys, knowledge management, training

* Technical Skill [Required]

• CMMI
• ISO 13485 / ISO 62304 / IEC 14971
• AS 9100
• ISO 9001
• Experience in Process Definition/ Improvement/ Implementation
• Software Quality Assurance
• Proficiency in Project Management
• Sound knowledge of Product Lifecycle Management
• Understanding of audit cycles and processes
• Good in MS Excel, Project, Word and Presentation
• Six Sigma
• VBA Programming

* Soft Skills [Required]

• Positive attitude & Good team player
• Excellent communication (written and oral), presentation & interpersonal skill

• Ability to work independently and collaboratively

• Ability to prioritize and manage work to critical project timelines in a fast-paced environment

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