Company
Supply Chain Services
SeniorQualityEngineer(Level-2)
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Quality Engineer( Level-2). Skills: Quality audits, Software Quality Assurance, Process Implementation. Performing quality audits. Understanding software lifecycle”
Industry & Context.
What They're Looking For.
Must Have
ISO 9001, ISO 13485, ISO 14971, IEC 62304, IEC 60601, Software Safety classification, DHF, Risk Management File, FMEA, DMR, Problem Reports, Quality Management System, Process Definition, Process Improvement, Process Implementation, Software Quality Assurance, Project Management, Product Lifecycle Management, audit cycles, MS Excel, MS Project, MS Word, Presentation, VBA Programming, Positive attitude, Good team player, Excellent communication, interpersonal skill, Ability to work independently, Ability to work collaboratively, Ability to prioritize, manage work to critical project timelines
Nice to Have
FDA/EUMDR dossier knowledge, HIPPA/GDPR/DPDP knowledge
What You'll Do.
Performing quality audits
Understanding software lifecycle
Facilitating projects
Writing quality management system
Updating quality management system
Implementing quality management system
Prepare Management Reviews
Present Management Reviews
Conduct QMS activities
Take global initiatives
How You'll Work.
Team & Collaboration
Ability to work collaboratively
Communication Scope
Excellent communication; presentation skill; interpersonal skill
Process & Methodology
Project Management, manage work to critical project timelines
Full 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 time # # **Job Category:** Supply Chain Services
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