Software Device Quality Engineer

  • location: Cambridge, MA
  • type: Contract
  • salary: $60 - $63 per hour
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job description

Software Device Quality Engineer

job summary:
Responsible for the quality oversight of design control and risk management for software as Medical Device. Manage review and approval of SDLC deliverables in accordance with Software as Medical Device and Design Controls procedures. Review and approve plans, protocols and reports generated as part of the software development process. Determine and enforce quality and safety requirements in accordance with company needs.

 
location: Cambridge, Massachusetts
job type: Contract
salary: $60 - 63 per hour
work hours: 9am to 5pm
education: Bachelors
 
responsibilities:
- Manage review and approval of SDLC deliverables in accordance with Software as Medical Device and Design Controls procedures.

- Review and approve plans, requirement specifications, test protocols and reports generated as part of the software development process.

- Represent Device Quality on cross-functional teams in support of SDLC activities.

- Act as subject matter expert in developing and revising validation documents ensuring compliance with regulatory requirements for medical devices with software

- Review and approve risk management documents

- Review and approval for quality issues (e.g. deviation) and technical matters (e.g. design changes and verification) with impact to design control and risk management

 
qualifications:
At a minimum Experience in computerized system validation within a regulated environment - Knowledge of IEC 62304, Medical Device Software - Software Life Cycle processes - Knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements Bachelor's or Master's degree in Life Sciences or Software Engineering

 
skills: - Manage review and approval of SDLC deliverables in accordance with Software as Medical Device and Design Controls procedures.

- Review and approve plans, requirement specifications, test protocols and reports generated as part of the software development process.

- Represent Device Quality on cross-functional teams in support of SDLC activities.

- Act as subject matter expert in developing and revising validation documents ensuring compliance with regulatory requirements for medical devices with software

- Review and approve risk management documents

- Review and approval for quality issues (e.g. deviation) and technical matters (e.g. design changes and verification) with impact to design control and risk management

- At a minimum Experience in computerized system validation within a regulated environment - Knowledge of IEC 62304, Medical Device Software - Software Life Cycle processes - Knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements Bachelor's or Master's degree in Life Sciences or Software Engineering


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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