Software Validation Manager- TalentZok
OVERVIEW
Are you looking for a new career opportunity with an exciting company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Software Validation Manager in Garden Grove, CA who possesses:
- 5 years' experience with software/firmware validation (preferably in Medical Device or IVDR sector)
- Knowledge of FDA regulations
- Bachelor's Degree in Computer Science or similar
Email resumes to kbrace@talentzok.com or call 858.683.8559
FULL DESCRIPTION:
The selected candidate will be responsible for:
- Provide translation from Mandarin to English and vice versa during meetings and other general communications.
- Provide translation from Chinese to English for requirements, defects, test protocols and other general written communications.
- Must be able to translate software and firmware terms between the two languages effectively.
- Perform testing on the instrument using good documentation practices.
- Knowledge of FDA guidelines for documentation control and validation for medical devices.
- Direct experience marshaling software through the FDA or IVDR, and who understands how to properly test software to meet those goals.
- Assign test cases and defects to testers balancing the workload.
- Write and edit requirements for both software and firmware and fill in deficiencies.
- Write and edit test cases for both software and firmware.
- Review test runs/protocols and identify defects or improvements for the software and firmware.
- Evaluate and fill in deficiencies in the software and firmware testing/validation.
- Write validation reports for software and firmware.
- Able to manage a diverse team across various time zones.
- Provide schedules for projects based on currently available resources, complexity, and timeline.
- Knowledge of FDA guidelines for documentation control and validation for medical devices.
- Write and edit Hazard Analysis, Software Description, and Software Project Plan documents.
- Review customer complaints and determine validity and priority for software/firmware fixes.
- Able to prioritize work among assigned projects and complete within schedule.
- Knowledge of Smartsheet for project scheduling a plus.
- Knowledge of Helix for defect tracking, requirements, and test protocols a plus.
The selected candidate will also possess:
- Bachelor degree in Computer Science
- Strong oral and written communication skills in English and Mandarin/Chinese are required.
- Ability to interact well with other departments, here in the US, Europe, and in China.
- Detailed understanding of good laboratory procedures and practices.
- Ability to handle multiple assignments with efficiency.
- Must be detailed-oriented.
- Knowledge of medical instrumentation, laboratory techniques and equipment.
- Must be able to apply basic principles, theories and concepts to practical problem solving.
- 5-10 years of software/firmware validation or other engineering experience, preferably in the medical devices or invitro diagnostics sector.
- Familiarity with FDA regulations as they relate to medical device, software/firmware validations, ISO-certified environment preferred.
- Experience working in a laboratory environment following GLP.
- Knowledge of software/firmware bug/defect tracking.
Salary Range: $90k-$120k/yr
For immediate and confidential consideration, please email your resume to kbrace@talentzok.com or call 858.683.8559. More information can be found at www.talentzok.com
