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Software Validation Engineer @217 FLEXTRONICS TECHNOLOGIES (INDIA) PRIVATE LIMITED

[Hiring] Software Validation Engineer @217 FLEXTRONICS TECHNOLOGIES (INDIA) PRIVATE LIMITED

Mar 29, 2025 - 217 FLEXTRONICS TECHNOLOGIES (INDIA) PRIVATE LIMITED is hiring a remote Software Validation Engineer. 💸 Salary: unspecified. 📍Location: India.

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Role Description

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 Location. Reporting to the Manager, the role involves:

  • 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).
  • Conducts 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.

Qualifications

  • 5 - 10 years of experience in Medical/Life Sciences industries software validation and compliance reviews.
  • 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.

Benefits

  • Health Insurance
  • PTO
  • NK99

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📍 Be aware of the location restriction for this remote position: India
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Back to Remote jobs  >   Software Development
Software Validation Engineer @217 FLEXTRONICS TECHNOLOGIES (INDIA) PRIVATE LIMITED
Software Development
Salary 💸 unspecified
Remote Location
India
Job Type full-time
Posted Mar 29, 2025
Apply for this position Unlock 54,693 Remote Jobs
️
📍 Be aware of the location restriction for this remote position: India
‼ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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