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QA Lead

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QualiTest is looking for a QA Lead in Concord, CA.

Hands on subject matter expert in the field of setting up systems for production, testing and calibration using both software and hardware. Responsible for validating the systems from the ground up, ensuring compliance, such that the data becomes a secure part of the device history record.

DAY-TO-DAY RESPONSIBILITIES

  • Manage/Lead the team effort
  • Establish validation standards and develop testing protocols
  • Leading the development and validation of automated test and calibration systems for kidney dialysis systems
  • Work with automation team and SQA Lead to define what to automate and who can do what.
  • Document test results and maintain records for later analysis
  • Coordinate and communicate between V&V team and other departments
  • Compose reports and make adjustments to equipment or processes that require improvement
  • Partners with and/or leads Business Teams and IT to ensure that computerized quality systems are compliant with corporate procedures, FDA Quality System Regulations, 21 CFR Part 11 and GAMP5
  • Leads and coordinates multiple software validation projects
  • Creates and/or oversees the creation of validation deliverables including but not limited to Validation Assessments, Validation Plans, Test Plans, Test Protocols, Test Reports, test scripts, Validation Summary Reports and Trace Matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment
  • Leads the review and approval of validation deliverables
  • Leads Business Owners/teams and IT in the definition and creation of Business Requirements, Functional Specifications and System Specifications as necessary
  • Communicates project and compliance issues to Quality Systems management and provide solutions to mitigate potential risks
  • Develops and manages Internal and External regulatory audits/ inspections by presenting and defending system validation projects and documentation during audits and FDA inspections as Subject Matter Expert
  • Work with little to no supervision to fulfill duties in accordance with requirements of the QSR regulations, GAMP5, Corporate policies and procedures
  • Follows all policies, guidelines, and SOP’s as required
  • Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
  • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
  • Provides assistance to other staff with complex tasks that require considerable judgment and initiative

JOB REQUIREMENTS (SKILLS/ EXPERIENCE)

  • MUST have experience in the medical doman (medical devices HIGHLY preferred)
  • MUST have experience managing the automation effort (Knowledge of various automation tools)
  • Experience leading the development and validation of automated test and calibration systems for medical devices
  • Develops and validates fixtures for system test.
  • Develops and validates test software reporting (informs device history record. i.e. Ensures compliance with FDA 21CFR Part 11 requirements.)
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.  Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Provides assistance to junior staff with complex tasks that require considerable judgment and initiative.
  • Mentors other staff as applicable.

Why QualiTest?

  • Opportunity to gain hands on experience by working with Testing Specialists in many different projects and industries.
  • We have developed one of the best learning and training platforms exclusively for our employees to build better testers
  • As a global company, we offer unique placement opportunities around the world. Even our CEO started as a Junior in Israel.
  • Our QualiTesters are the reason for our success, we constantly encourage career development and promote from within.

Intrigued to find more about us?

  • Visit our website at www.qualitestgroup.com 
  • For more job openings, check our Career page: http://qa-jobs.qualitestgroup.com/

If you like what you have read, send us your resume and let’s start talking!

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