Job Description
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 timeJob Category:
Supply Chain Services
Innovation isn’t powered by machinery. It’s powered by people. Together, we think bigger. We listen and learn. We explore and solve. We’re a team of many backgrounds and places, working toward one common goal: To help customers build the tangible future, where innovation improves quality of life and the benefits of technology are more accessible to all. Join us.