Name variants:
Renuka Ramachandran
Last updated Jun 13, 2024
Contact Information
Workplace
Colleagues
Work History
Associate Director, Software Design Compliance
1525 Obrien Dr, Menlo Park, CA 94025
Quality lead on software technology applications and bioinformatics pipelines
Validation lead (FDA CSV) on Off-the-Shelf (OTS) software
Supporting software and bxds teams on adopting best...
from Apr 2018
Staff Quality Engineer
1820 Mccarthy Blvd, Milpitas, CA 95035
Collaborate with the mobile app, embedded software/firmware engineering teams, data scientists, and dev/ops team to develop software Design Control procedure
Review validation activities f...
Mar 2017 — Apr 2018
Staff Design Qualityengineer, Informatics
5200 Illumina Way, San Diego, CA 92122
Develop Design Control procedures and Software Development Life Cycle (SDLC) process in compliance with FDA Quality System Regulation (QSR) and ISO regulations for products offered as SaaS
...
Mar 2015 — Feb 2017
Manager, System Software Qa
500 Plaza Dr, Secaucus, NJ 07094
Manage team on multiple projects for FDA approval and CE Mark.
Work with Project and Program Managers while representing the instrument system and software team.
Provide information for p...
Apr 2012 — Apr 2015
Senior System Software Qa Engineer
1401 Harbor Bay Pkwy, Alameda, CA 94502
Team representative in core team meetings to communicate task status for projects.
Attended review meetings for Design Control documents including Project plan, Risk, Development plan, Des...
Jan 2009 — Mar 2012
System Software Qa Engineer
81 Wyman St, Waltham, MA 02451
Trained on DNA sequencing technology.
Performed V & V activities for data analysis software for ABI genetic analyzer data (ABI 3100 and ABI 3130).
Drafted IQ/OQ/PQ protocols for LIMS soft...
Apr 2007 — Dec 2008
Instrument System Qa
1000 Alfred Nobel Dr, Hercules, CA 94547
Validated Bio-Rad's Profinia Software for Profinia Instrument (a Low Pressure Liquid Chromatography system for Protein Purification).
Responsible for all V & V activities, including ensuri...
Jul 2006 — Mar 2007
Instrument Software Qa
5301 Stevens Creek Blvd, Santa Clara, CA 95051
System validation of High Pressure Liquid Chromotography (HPLC) and Gas Chromatography (GC)
Apr 2001 — Feb 2005
Education
Occupations
Executive
Deputy Director
IT Professional
Software Engineer
Engineer
Quality Engineer
Software Tester
Sales Specialist
Supplier
Deputy Manager
Chief Executive
Software Developers
Compliance Engineer
Computer Specialist
Services Professional
Sales Representative
Skills
Validation
Quality Assurance
Medical Devices
Biotechnology
Testing
Hplc
Chromatography
Life Sciences
Agile Methodologies
U.s. Food and Drug Administration
Quality System
Software Quality Assurance
Gmp
Iso 13485
High Performance Liquid Chromatography
Computer System Validation
Capa
Corrective and Preventive Action
Verification and Validation
Design Control
Cross Functional Team Leadership
Medical Device Validation
Sequencing Instrumentsystem/Software Testing
Scrum
Hipaa
21 Cfr Part 820
Iso 14971
Iso 27001
Complaint Management
FAQs about Renuka Ramachandran
What's the main profession of Renuka Ramachandran?
Renuka Ramachandran is a Associate Director, Software Design Compliance.
What jobs is Renuka Ramachandran a professional at?
Renuka Ramachandran is a professional Executive and Deputy Director jobs.
Where does Renuka Ramachandran live?
They lives in San Francisco, California.
How many companies did Renuka Ramachandran work at?
The professional worked at eight jobs.
Where has Renuka Ramachandran studied?
Renuka studied at the University of California, Santa Cruz from 2008 to 2009.
What are the certifications of Renuka Ramachandran?
This expert received the following certifications: License 8500177-152748, Sequencing Technology, Risk-Based Validation of Medical Devices, and License 000328434.
What languages does Renuka Ramachandran speak?
Renuka Ramachandran speaks English, Hindi, and Tamil.
Are there any special industries, that Renuka Ramachandran works in?
Renuka works in Medical Devices industry.