Position
Senior Quality Engineer( Level-2)
Job Description
- * Detailed Description of the Job Profile (Role and Responsibility)
Performing quality audits as per ISO 9001 and ISO 13485 and related harmonized standards (ISO 14971, IEC 62304, IEC 60601 etc)
- Understanding of software lifecycle
- Guiding and facilitating projects for effective process & metric s implementation
- Work product reviews(Software Safety classification, DHF, Risk Management File, FMEA, DMR, Problem Reports etc) for quality and process
- Writing, updating and implementation of quality management system
- Conducting ISO 13485 and harmonized standard's process 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
Key Skills
*
- ISO 13485
- ISO 9001
- FDA/EUMDR dossier knowledge
- HIPPA/GDPR/DPDP knowledge
- 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
- 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
Location:
IN-GJ-Ahmedabad, India-Ognaj (eInfochips)
Time Type
Full time
Job Category
Supply Chain Services
