Product Compliance Engineer

San Francisco
Quality
Full-time
The Software Quality Engineer position is responsible for the development of department procedures related to the design and development of the Vineti Platform, as well as the development and execution of test plans.  The candidate should have strong problem solving skills, the ability to learn new technology quickly and adjust to a dynamic work environment.    

WHAT YOU'LL BE DOING:

    • Supports the development of the software development deliverables associated with GAMP 5, GDPR, and Part 11  
    • Lead major efforts, or phases of projects, to resolve advanced and complex technical and Software Quality-related problems
    • Lead/support Risk Management activities to ensure software design and process shortcomings are identified and appropriately addressed
    • Support the product development teams in the adoption and use of best practices, Quality tools, and Software Design Control methodologies
    • Monitoring and developing software reliability improvements to existing & new design
    • Develop & maintain verification and validation plans and procedures, including risk management for software projects
    • Develop, organize and perform software verification and validation test procedures.
    • Develop automated test verification plans & procedures
    • Support the investigation into the feasibility of new projects, systems or approaches
    • Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR and ISO 9001
    • Develop and implement quality metrics associated with software development and performance
    • Oversee/Support Software Quality System sub-systems as directed by senior management, i.e. CAPA, Internal Audits, etc.

THE FOLLOWING EXPERIENCE AND SKILLS ARE IMPORTANT TO US:

    • Bachelor's Degree in Engineering or Computer Science, or equivalent experience
    • 7+ years related Software Quality Assurance/Quality Engineering experience 
    • 4+ years experience with embedded software or real-time devices/systems level testing required 
    • ASQ Certification(s) a plus, Six Sigma experience highly desirable
    • Excellent working knowledge of GAMP 5, FDA Quality System Regulation 21 CFR Part 820, or ISO13485 required
    • Excellent verbal communication and technical writing skills
    • Ability to interface with multiple groups in the organization
    • Experience with structured programming languages and scripting desired
    • Software - Computer skills – C++, C, Java and object oriented design, embedded software design and automated testing, data security

COMPANY CULTURE AND BENEFITS:

    • Mission-driven and passionate about solving complex problems in healthcare / personalized medicine that expand patient access to life-saving therapies
    • Significant career opportunities at a rapidly growing company backed by major venture capital firms
    • Competitive salaries with stock option plan
    • Health and dental benefits, 401K
    • Pre-tax commuter benefits
    • Flexible work hours/remote work supported when needed
    • Open vacation policy - take time when you need it