Software Validation Engineer
2 weeks ago
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a/an Software Validation Engineer - IT located in Coimbatore / Chennai / Remote.
Reporting to the Senior Manager, the role involves…
What a typical day looks like:
Good Experience in executing Medical industries software validations, having led and managed projects.
Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities including 21 CFR 820, 21 CFR Part 11, ISO 14971, ISO 13485, FDA, EU Medical Device Regulation, GAMP, GPSV, and CSV/CSA
High-level strategic problem-solving and reasoning skills. Analyzes evaluates and presents information concerning findings, trends with IT in business, and development.
Ensure adherence to software validation processes and perform review & approval for all the software validation activities.
Suggests and debates to implement the right SDLC, software validation methods, and procedures with Flex.
Train and coach project team members on achieving quality in project deliverables (e.g. GDP, V&V Process, CSV, project-related risks management, resolving the issues by following the right process, and SOP requirements).
Conduct meetings (technical & management) to review investigation findings related to IT systems.
Cooperates with other department personnel and peers in understanding needs and identifying opportunities for improvements.
Serve as the SME for CSV, maintaining the knowledge and information in the CSV area of expertise.
Perform software validation activities
Liaise between IT, Quality, Project Team, Corporate Quality team, and various regulatory bodies.
Keep abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control.
Prepare reports for senior management and external regulatory bodies as appropriate.
Escalate non‐compliance with a resolution for the fundamental CSV compliance issues.
Support the project team to perform audit readiness and project audits.
Expected to travel (domestic/internationally) when needed to meet with Flex facility project Teams.
Work collaboratively with different departments located in a different geography.
The experience we’re looking to add to our team:
Any graduate or Master degree
5 - 8 years of experience in Medical/Life Sciences industries software testing.
Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities including 21 CFR 820, 21 CFR Part 11, ISO 14971, ISO 13485, FDA, EU Medical Device Regulation, GAMP, GPSV, and CSV/CSA
High-level strategic problem-solving and reasoning skills. Analyzes evaluates and presents information concerning findings, trends with IT in business, and development.
Ensure adherence to software validation processes and perform review & approval for all the software validation activities.
Suggests and debates to implement the right SDLC, software validation methods, and procedures with the Flex.
What you’ll receive for the great work you provide:
Health Insurance
PTO
-
Senior Front-End Software Engineer
3 days ago
Tamil Nadu, India RunLoyal: Pet Software Full time*Currently residing in Tamil Nadu, candidates to apply. No relocation assistance will be provided.*Preference for immediate joiners.Job Title: Senior Front-End Software EngineerCompany: RunLoyal Location: Tamil Nadu Only (Hybrid)Summary: RunLoyal, a rapidly growing vertical SaaS company based in Atlanta, GA, seeks a passionate and experienced Front-End...
-
Senior Front-End Software Engineer
2 days ago
Tamil Nadu, India RunLoyal: Pet Software Full time*Currently residing in Tamil Nadu, candidates to apply. No relocation assistance will be provided. *Preference for immediate joiners. Job Title: Senior Front-End Software Engineer Company: RunLoyal Location: Tamil Nadu Only (Hybrid) Summary: RunLoyal, a rapidly growing vertical SaaS company based in Atlanta, GA, seeks a passionate and experienced...
-
Validator / Developer - CATIA
2 weeks ago
tamil nadu, India Renault Nissan Technology & Business Centre India Full timeExperience - (3-10) yearsSkillsAdvance CAD/PDM skillsStrong knowledge on CATIA/CATScript/EKLMust have CAD customization experience in Automotive CAD/PDMMechanical Engineering domain knowledge like Electrical, Architecture, Interior/Exterior, etc…Hands on experience in CATIA/3D Exp/CATScript/VBS/VBA/EKLEducation - BE, B.TechResponsibilitiesUnderstand the...
-
Software Engineer
2 weeks ago
tamil nadu, India RRD GO Creative Full timeAbout us: RRD GO Creative™, with more than three decades of expertise in business communications, marketing solutions, and digital productivity solutions, we successfully help reimagine customer experiences for companies. Our three pillars of Global Brand Solutions, Smart Work Solutions, and Technology & Innovation Services transform the way businesses...
-
Senior Software Test Engineer
2 weeks ago
tamil nadu, India KANINI Full timeSenior Testing Automation EngineerWe are seeking an experienced Senior Testing Automation Engineer with a strong background in C# and Selenium. The ideal candidate will have at least 8 years of experience in software testing and automation, with proven expertise in leading teams and the ability to function as an individual contributor when needed. This role...
-
Software Engineer
2 weeks ago
tamil nadu, India Five9s Solutions Ltd Full timeCompany DescriptionFive 9s Solutions is a premier IT service provider based in United Kingdom, specializing in delivering innovative and cost-effective IT solutions to businesses globally. Our mission is to empower clients with purpose-driven IT services tailored to their individual needs, enabling a seamless digital transformation journey. We focus on...
-
Senior Software Engineer
2 weeks ago
tamil nadu, India Bahwan CyberTek Full timeSkills• Bachelor’s degree in computer science, Information Technology, Engineering, or a related field.• Minimum of 6 years of experience working with IBM Maximo/ MAS, including system implementation and configuration.• Proven experience with Maximo/MAS customization, scripting, and integration.• Experience in the deployment and implementation of...
-
Software Engineer
2 weeks ago
tamil nadu, India YouTrip Full timeWe AreYouTrip is at the forefront of Asia's financial revolution, defining the future of digital finance with its leading multi-currency payment platform. Launched in 2018, YouTrip has swiftly ascended as a powerhouse, orchestrating billions in transactions annually and securing the trust of millions. With innovative solutions like YouTrip for consumers and...
-
System Software Specialist
2 weeks ago
tamil nadu, India KLA Full timeJob DescriptionArchitect and Design High-Performance Compute Clusters :Collaborate with cross-functional teams to design, implement, and support HPC clusters.Optimize compute resources for maximum efficiency, considering CPU/GPU architecture, storage scalability, and high-bandwidth interconnects.Project Specifications and Timelines :Understand project...
-
Software Engineering Manager
4 months ago
tamil nadu, India IDFC FIRST Bank Full timeJob Purpose:The role involves managing squads independently, with a focus on microservices and cloud-native architecture. Exposure to AWS is a definite plus. If you are a hands-on leader with a passion for building scalable and robust systems, we want to hear from you. We are looking for a talented and experienced Software Engineering Manager with a strong...
-
Software Engineer
2 weeks ago
tamil nadu, India Sloka IT Solutions Full timeGreetings from Sloka IT Solutions.Job Title: OCR EngineerLocation: Chennai, IndiaWork Type: HybridExperience Level: 4-6 YearsDuration: 6 months (with possible extension)Job Details:OCR EngineerWe are looking for a growth-oriented software engineer to work with an AI product team to integrate the OCR Engine. A successful candidate will bring experience in...
-
Iot Testers
3 months ago
Chennai, Tamil Nadu, India Indium Software Full time**Job Information**: RSD NO **8887*** Industry **IT Services*** Min Experience **4 Years*** Max Experience **9 years*** City **Chennai*** State/Province **Tamil Nadu*** Country **India*** Zip/Postal Code **600018*** **Title**:iOT Testers** **Experience**: 4**-9 Years** **Work Location**:Chennai** **Work Mode**:Work from...
-
In-vehicle Infotainment Validation
3 months ago
Chennai, Tamil Nadu, India Subhanu Technologies and solutions pvt limited Full timeWork location : chennai Mode : work from office Experience: 1 to 5years - Experience in infotainment testing for the automotive domain. - Very good expertise in IVI (in Vehicle Infotainment) validation & verification - Working knowledge on HMI features and hands on working experience in ADAS Features. - Expert in analysing the requirements on different...
-
Senior Software Engineer
4 months ago
tamil nadu, India Veryon Full timeSenior Software Engineer – .NET Veryon (on-site)Why We Need You – The MissionVeryon is a global information services and software company that exists to make flying safer and more reliable. Our products help reduce operating costs, improve aircraft reliability, and support technical knowledge sharing and collaboration within the general, business, and...
-
Senior Software Quality Analyst
2 weeks ago
tamil nadu, India Uster Technologies Full timeJob DescriptionPosition: Senior Software QALocation: Uster Technologies India, CoimbatoreUster Technologies AG, Switzerland ( ) is the global leader for managing spinning mills with quality in mind. We provide a global cloud solution for spinning mills consisting of various cloud services. Together with your team you develop and provide specific cloud...
-
Sr. Software Engineer
4 months ago
tamil nadu, India Yield Engineering Systems Full timeYES (Yield Engineering Systems, Inc.) is a leading manufacturer of reliable, high-tech, cost-effective capital equipment that transforms materials and surfaces at the nanoscale. From startups to the Fortune 50, our customers rely on YES to help them unleash products that change lives – from cell phones and IoT devices to AI and virtual reality, to...
-
Senior Software Engineer
2 weeks ago
tamil nadu, India D2R AI Labs Full timeSenior Software EngineerThe Senior Software Engineer is accountable for driving automation and streamlining operations to enhance efficiency. Possessing a strong background in Python, with a particular focus on pandas, numphy and FastAPI frameworks. Experience with databases such as MongoDB and TimescaleDB (Postgres) or any time series database is essential....
-
Senior Software Engineer
2 weeks ago
tamil nadu, India Anthology Inc Full timeSenior Software EngineerChennai, IndiaThe Opportunity:Anthology delivers education and technology solutions so that students can reach their full potential and learning institutions thrive. Our mission is to empower educators and institutions with meaningful innovation that’s simple and intelligent, inspiring student success and institutional growth.The...
-
Manager, Software Engineering
2 weeks ago
tamil nadu, India KLDiscovery Full timeKLDiscovery, a leading global provider of electronic discovery, information governance and data recovery services, is currently seeking a Manager, Software Engineering position.The person will develop and maintain software applications in support of KLDiscovery’s family of products and services. Oversee software development projects and report on...
-
Software Engineer
3 weeks ago
Tamil Nadu, India Guidanz Inc Full timeJob Description:Guidanz Inc. is seeking a Software Engineer(Backend). The role involves using your technical knowledge and expertise to develop and maintain high-performance backend applications. You will play a crucial role in designing, implementing, and optimizing the core functionalities of our software products.We are an entrepreneurial, talented, and...