Senior Quality Engineer( Level-2)
* Detailed Description of the Job Profile (Role and Responsibility)
Performing quality audits as per ISO 9001and ISO 13485 and related harmonized standards (ISO 14971, IEC 62304, IEC 60601etc)
Understanding of software lifecycle
Guiding andfacilitatingprojects for effective process &metricsimplementation
Work productreviews(Software Safety classification, DHF, Risk Management File, FMEA, DMR, Problem Reportsetc)for quality and process
Writing,updatingand implementation of quality management system
ConductingISO 13485 and harmonizedstandard’sprocesstrainings
Prepare & Present Management Reviews
Defining processes andconductQuality 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
FDAEUMDR dossierknowledge
HIPPA/GDPR/DPDP knowledge
Experience in Process Definition/ Improvement/ Implementation
Software Quality Assurance
Proficiencyin Project Management
Sound knowledge of Product Lifecycle Management
Understanding of audit cycles and processes
Good in MS Excel, Project,Wordand Presentation
VBA Programming
* Soft Skills [Required]
Positive attitude & Good team player
Excellent communication (written and oral), presentation & interpersonalskill
Ability to work independently and collaboratively
Ability to prioritize and manage work to critical project timelines in a fast-paced environment
IN-GJ-Ahmedabad, India-Ognaj (eInfochips)
Full time
Supply Chain Services
Arrow Electronics (NYSE:ARW) guides innovation forward for thousands of leading technology manufacturers and service providers. With 2024 sales of $27.9 billion, Arrow develops technology solutions that help improve business and daily life.
Our broad portfolio that spans the entire technology landscape, helps customers design, distribute and deploy forward-thinking products that make the benefits of technology accessible to as many people as possible. Learn more at arrow.com.
Are you thinking Five Years Out? Join us at careers.arrow.com.
