About the role

Aplyr's Quick Take

This role is for a Senior Quality Engineer focused on ensuring compliance with ISO standards in a software environment. Day-to-day tasks include conducting quality audits, facilitating process improvements, and reviewing documentation for quality assurance. It's primarily an individual contributor role with some project management responsibilities.

Good fit

Ideal candidates have several years of experience in quality engineering, particularly with ISO 13485 and ISO 9001 standards. A proactive, detail-oriented approach and strong communication skills are essential for success in this fast-paced environment.

Worth noting

The role emphasizes both technical quality assurance and process management, which may appeal to those looking to blend engineering with project oversight. The requirement for knowledge in FDA/EUMDR regulations suggests a focus on medical software, which could be a niche area of expertise.

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

Aplyr's read

Arrow Electronics is a key player in technology solutions, employing a diverse workforce from engineers to sales professionals to drive innovation in electronics distribution.
Synthesized from recent postings & public sources

What's promising

•Strong global presence with operations in over 80 countries, offering vast career opportunities.
•Diverse role offerings from engineering to sales, catering to various career paths.
•Focus on cutting-edge technology solutions, keeping employees at the forefront of industry advancements.

What to watch

•Highly competitive industry may lead to pressure on margins and job security.
•Complex organizational structure could lead to bureaucratic challenges.
•Rapid technological changes require constant skill updates, potentially increasing employee stress.

Why Arrow Electronics

•Specializes in both electronic components and enterprise computing solutions, offering a broad industry scope.
•Strong emphasis on innovation, reflected in diverse engineering and technical roles.
•Global distribution network provides employees with international exposure and opportunities.

Aplyr’s read is generated by AI from public sources. Was it useful?