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Validation and Verification Team Lead

Are you a QualiTester?

QualiTest is looking for a Validation and Verification Team Lead in Concord, CA.

If you’re passionate about testing, we want to talk to you!

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?

JOB DESCRIPTION

  • Manage and work with a team of test engineers
  • Evaluate and calibrate the equipment and procedures
  • Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products
  • Testing Medical Devices and Equipment in an FDA regulated environment
  • Perform Validation and Verification Testing
  • Perform Functional Testing 

DAY-TO-DAY RESPONSIBILITIES

  • Manage/Lead the team effort
  • Establish validation standards and develop testing protocols
  • 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)

  • Bachelor’s or Master’s in Computer Science, Software Engineering, Biomedical Engineering or related field
  • MUST have 2+ years of medical device experience (preferred) or medical domain experience or experience tested embedded software (software with a hardware device)
  • MUST have 2+ years of Validation and Verification experience
  • MUST have experience leading/managing a team
  • Thorough understanding of FDA Quality System regulations in relation to computer system validation
  • ASQ CSQE Certification or equivalent preferred
  • Extensive experience with one or more of the following highly desirable: SAP, PTC WindChill, Pilgrim
  • Excellent verbal and written communication skills
  • Excellent team work and interpersonal skills
  • Experience with spreadsheet validation
  • Experience with hardware, oracle databases and cloud technology
  • Very strong analytical and problem solving skills
  • Excellent attention to detail, resourceful, self-reliant, self-motivated and confident
  • Has project management, deep analytical and problem solving skills
  • Ability to track defects and verify resolutions with different levels of urgency

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

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