Medical Devices Software Quality Specialist

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Medical Devices Software Quality Specialist

At GxPeople Global, we're seeking a seasoned Software Quality Engineering Specialist with proven expertise in the Medical Device industry. Join our esteemed medical device client and play a pivotal role in elevating quality operations while contributing to the advancement of cutting-edge medical technologies worldwide.

 

The Engineering Quality Specialist supports: the product development process, requirement

planning and reviews, verification planning, review of test case methods, & defect management and related risk assessments. Additionally, this position will support and improve medical devices with an emphasis on software and related development, configuration, and release processes.

 

Responsibilities

  • The Software Quality Engineering Specialist will develop and implement quality assurance processes for medical device software in compliance with industry standards and regulations (IEC/ISO 62304 Medical Device Software Lifecycle and 21 CFR 820.30 Design Controls)
  • Assure thorough testing and validation of software and hardware systems to ensure they meet specified requirements and are free from defects.
  • Collaborate with cross-functional teams to define quality metrics, standards, and procedures throughout the software development life cycle.
  • Assist with cross functional risk assessments and contribute to the creation of risk management plans related to software quality.
  • Reviews to assure that verification test plans, verification test cases, and validation protocols are complete and will provide meaningful results to assure design output met the design input
  • Participate in audits and inspections to ensure compliance with relevant quality standards and regulations.
  • Investigate and analyze reported product defects, providing detailed and accurate reports to support corrective actions.
  • Facilitate communication between development teams and regulatory affairs to address quality-related issues.
  • Contribute to continuous improvement initiatives by leading complaint investigations and CAPAs.
  • Review design specifications for clarity and testability
  • Participate in design reviews for new products
  • Establish quality plans for new products
  • Facilitate pre-and-post-market risk management activities
  • Maintain records to assure regulatory compliance

 

Requirements

  • Required: Bachelor’s degree in Engineering or related field
  • Greater than 8 years of related experience in the medical device industry or equivalent combination of education and experience
  • Demonstrated knowledge of IEC/ISO 62304 Medical Device Software Lifecycle and 21 CFR 820.30 Design Controls
  • Experience with FDA regulations, specifically medical device software
  • Experience in compliance to GMPs
  • Excellent leadership and communication skills
  • Ability to mentor junior staff

 

** Only US citizens or green card holders can be considered for this role**

 


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