Job Description
Flex is hiring for The Software Validation Engineer will be based in Chennai.
.We are looking for someone who demonstrates
Intense collaboration
Passionate customer focus
Thoughtful, fast, disciplined execution
Tenacious commitment to continuous improvement
Relentless drive to win
Here is a glimpse of what you will do:
Knowledge of software testing in medical/life sciences industries.
Participate in cross-functional teams discussion as needed and work collaboratively with all departments.
Establish clear communication channels and ensure proper feedback mechanisms are in place with customers, peers, and cross-functional teams.
Analyze and summarize the results of validation activities using valid statistical practices.
Design training material and work instructions for the defined processes.
Support project teams and assist with software validation process/activities.
Train and coach the project team about software validation deliverables to ensure knowledge transfer, understanding, and timely support in software validation activities.
Provides liaison to various regulatory bodies.
Ability to communicate with right manager/person/group by writing reports, business correspondence, and challenges including risk and GAPs at right time.
Here is some of what you will need (required):
4- 7 years of experience in Medical/Life Sciences industries software testing
Knowledge of 21 CFR 820, 21 CFR Part 11, ISO 13485, and ISO 14971.
Design and execute the software validation activities to meet compliance with FDA specifications and Change control.
Understand the organization's Standard Operating procedures and support required execution.
Author verification and validation test scripts.
Execute verification and validation test scrips.
Support to perform code review.
Do peer reviews of all the CSV deliverables.
Here are a few of our preferred experiences:
Software validation experience in the medical/medical device industries.
Knowledge in test automation tools.
Bachelors degree in related field or equivalent experience.
Knowledge in CSA.
Knowledge in QMS
If You are interested for contract position then please share your updated resume to Su**************m@fl*x.com
Supriya
Executive - Talent Acquisition
email: Su**************m@fl*x.com
web: flex.com
RMZ Millennia Business Park, Level 7, Campus II No.143,
Dr MGR Road, Kandanchavadi, Chennai, India 600096
Job Classification
Industry: Medical Devices & Equipment
Functional Area: IT Software - QA & Testing,
Role Category: Programming & Design
Role: Programming & Design
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any Specialization
Post Graduation: Any Postgraduate in Any Specialization
Doctorate: Any Doctorate in Any Specialization, Doctorate Not Required
Contact Details:
Company: Flextronics Technologies(I) Pvt Ltd
Location(s): Chennai
Keyskills:
CSV Engineer
Software Validation Engineer
Computer software validation
Software Validation