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Manager of Software Validation

2 months ago

Garden Grove, California, United States TalentZok Full time
Job Overview

Position: Software Validation Manager

SUMMARY

We are seeking a dedicated professional to join our dynamic team. In this role, you will oversee critical responsibilities as outlined below.

We have an immediate opening for a Software Validation Manager who possesses:

  • Bilingual proficiency in English and Mandarin
  • A minimum of 5 years' experience in software or firmware validation, ideally within the Medical Device or IVDR sectors
  • Familiarity with FDA regulations
  • A Bachelor's Degree in Computer Science or a related field

DETAILED RESPONSIBILITIES:

The selected candidate will be accountable for:

  • Facilitating translation between Mandarin and English during meetings and other communications.
  • Translating documentation such as requirements, defects, and test protocols from Chinese to English.
  • Effectively translating software and firmware terminology between both languages.
  • Conducting instrument testing while adhering to rigorous documentation standards.
  • Applying knowledge of FDA guidelines for documentation control and validation specific to medical devices.
  • Directly managing the software validation process through FDA or IVDR compliance, ensuring proper testing methodologies are employed.
  • Distributing test cases and defects among testers to maintain a balanced workload.
  • Drafting and refining requirements for both software and firmware.
  • Creating and revising test cases for software and firmware.
  • Reviewing test runs and protocols to identify defects or areas for improvement.
  • Assessing and addressing deficiencies in software and firmware validation processes.
  • Preparing validation reports for software and firmware.
  • Managing a diverse team across multiple time zones.
  • Developing project schedules based on resource availability, complexity, and timelines.
  • Understanding FDA guidelines for documentation control and validation.
  • Writing and editing Hazard Analysis, Software Description, and Software Project Plan documents.
  • Evaluating customer complaints to determine their validity and priority for software or firmware resolutions.
  • Prioritizing tasks across various projects to ensure timely completion.
  • Familiarity with Smartsheet for project scheduling is advantageous.
  • Experience with Helix for defect tracking, requirements, and test protocols is a plus.

The ideal candidate will also have:

  • A Bachelor's degree in Computer Science
  • Strong communication skills in both English and Mandarin/Chinese
  • The ability to collaborate effectively with departments in the US, Europe, and China
  • A comprehensive understanding of good laboratory practices
  • The capability to manage multiple assignments efficiently
  • A detail-oriented approach
  • Knowledge of medical instrumentation and laboratory techniques
  • The ability to apply fundamental principles and concepts to solve practical problems
  • 5-10 years of experience in software or firmware validation or related engineering roles, preferably in the medical devices or in vitro diagnostics field
  • Familiarity with FDA regulations pertaining to medical device and software/firmware validations, with experience in an ISO-certified environment preferred
  • Experience in a laboratory setting adhering to GLP standards
  • Knowledge of software and firmware bug and defect tracking systems

Salary Range: $80k-$90k/year

About TalentZok

Founded in 2008, TalentZok has consistently been recognized as one of the fastest-growing companies in San Diego County. We were honored as the 'Best Places to Work' by Business Journal in 2022. While many competitors are reducing their workforce, TalentZok continues to expand into new markets and grow our team.