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Validation and Verification Test Engineer

Are you a QualiTester?

QualiTest is looking for a Validation and Verification Test Engineer 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

  • Work with a team of test engineers on medical devices and equipment
  • Evaluate and calibrate the equipment and procedures
  • Testing medical devices and equipment in an FDA regulated environment
  • Perform validation and verification testing
  • Perform functional testing Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products
  • Establish validation standards and develop testing protocols
  • Document test results and maintain records for later analysis

DAY-TO-DAY RESPONSIBILITIES

  • Coordinate and communicate between V&V team and other departments
  • Compose reports and make adjustments to equipment or processes that require improvement
  • Responsible for assuring projects meet customer expectations, and regulatory requirements
  • Provide guidance to engineering staff and other personnel and ensure that design control requirements and being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review
  • Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF for accuracy and completeness and provide guidance on FDA compliance and procedures
  • Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards
  • Assist in the development and maintenance of company procedures for design control, change management, risk management, test method validation, process validation and related areas of the quality management system
  • Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices

JOB REQUIREMENTS (SKILLS/ EXPERIENCE)

  • Bachelor’s or Master’s in Computer Science, Software Engineering, Biomedical Engineering or related field required
  • 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
  • Thorough understanding of FDA Quality System regulations in relation to computer system validation
  • Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements
  • Ability to multi-task and operate within a fast-paced environment
  • Excellent oral, written, analytical, computer and interpersonal skills
  • Functional Testing Experience
  • Proactive Individual who is self-motivated and confident

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

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