Talent.com
Quality System Specialist (Santa Clara)

Quality System Specialist (Santa Clara)

CruxxSanta Clara, CA, United States
5 days ago
Job type
  • Full-time
Job description

Quality Systems Specialist Medical Devices

Onsite 3 Days | Bay Area, CA | ~20% Travel

We are seeking a Quality Systems Specialist to join a growing medical device organization. This role is critical to supporting, maintaining, and improving the Quality Management System (QMS) in line with international regulatory standards.

What Youll Do

  • Maintain and improve QMS procedures, work instructions, processes, and records
  • Support supplier quality activities, including selection, qualification, and ongoing evaluations
  • Collaborate with R&D and Operations on inspections, non-conformances, and supplier issues
  • Contribute to CAPA investigations, root cause analysis, and effectiveness checks
  • Support training programs, audits (internal & external), and management reviews

What Were Looking For

  • Bachelors degree in engineering, life sciences, or related field
  • 3+ years experience in medical devices, IVDs, or life sciences within an FDA / ISO 13485-regulated environment
  • Working knowledge of FDA QSR, ISO 13485, and EU MDR
  • Experience with CAPA, auditing, inspections, and document control
  • Proficiency in Microsoft Office
  • Willingness to travel up to 20% and work onsite in 3 days a week in The Bay facility.
  • This is a great opportunity to play a key role in ensuring compliance and quality excellence in a highly regulated environment.

    If youre passionate about driving quality in medical devices and want to make an impact, wed love to hear from you.

    Create a job alert for this search

    Quality System Specialist • Santa Clara, CA, United States

    Related jobs
    • Promoted
    Quality Improvement Specialist

    Quality Improvement Specialist

    University of California - San Francisco Campus and HealthSan Francisco, CA, United States
    Full-time
    Quality Improvement Specialist.The Quality Improvement Specialist will provide quantitative and qualitative programmatic and data analysis support to the clinical enterprises and its growing portfo...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Systems Analyst

    Quality Systems Analyst

    SupermicroSan Jose, CA, United States
    Full-time
    Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop / Big Data, Hyperscale, HPC and IoT / Embedded customers...Show moreLast updated: 30+ days ago
    • Promoted
    Quality System Specialist (San Francisco Bay Area)

    Quality System Specialist (San Francisco Bay Area)

    CruxxSan Francisco Bay Area, US
    Part-time
    Quality Systems Specialist Medical Devices.Onsite 3 Days | Bay Area, CA | ~20% Travel.This role is critical to supporting, maintaining, and improving the. Quality Management System (QMS).Maintain a...Show moreLast updated: 5 days ago
    • Promoted
    Quality System Specialist (Fremont)

    Quality System Specialist (Fremont)

    CruxxFremont, CA, US
    Part-time
    Quality Systems Specialist Medical Devices.Onsite 3 Days | Bay Area, CA | ~20% Travel.This role is critical to supporting, maintaining, and improving the. Quality Management System (QMS).Maintain a...Show moreLast updated: 5 days ago
    • Promoted
    Quality System Specialist (Hayward)

    Quality System Specialist (Hayward)

    CruxxHayward, CA, US
    Part-time
    Quality Systems Specialist Medical Devices.Onsite 3 Days | Bay Area, CA | ~20% Travel.This role is critical to supporting, maintaining, and improving the. Quality Management System (QMS).Maintain a...Show moreLast updated: 5 days ago
    • Promoted
    Quality Control Manager (Santa Clara)

    Quality Control Manager (Santa Clara)

    Ground Up Construction RecruitingSanta Clara, CA, United States
    Full-time
    Ground Up Construction Recruiting.They specialize in federal government, public works, and healthcare projects.The first project you'll start on is a $20M healthcare facility in Fairfield.Medical, ...Show moreLast updated: 5 days ago
    • Promoted
    Quality System Specialist (San Francisco)

    Quality System Specialist (San Francisco)

    CruxxSan Francisco, CA, US
    Part-time
    Quality Systems Specialist Medical Devices.Onsite 3 Days | Bay Area, CA | ~20% Travel.This role is critical to supporting, maintaining, and improving the. Quality Management System (QMS).Maintain a...Show moreLast updated: 5 days ago
    • Promoted
    Quality System Specialist (Alameda)

    Quality System Specialist (Alameda)

    CruxxAlameda, CA, US
    Part-time
    Quality Systems Specialist Medical Devices.Onsite 3 Days | Bay Area, CA | ~20% Travel.This role is critical to supporting, maintaining, and improving the. Quality Management System (QMS).Maintain a...Show moreLast updated: 5 days ago
    • Promoted
    Sr Specialist, Quality Systems Technology (QST)

    Sr Specialist, Quality Systems Technology (QST)

    Corcept TherapeuticsRedwood City, CA, US
    Full-time
    Specialist Veeva Quality (QMS & QualityDocs) And ComplianceWire.Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the g...Show moreLast updated: 30+ days ago
    • Promoted
    Quality System Specialist

    Quality System Specialist

    CruxxSunnyvale, CA, US
    Full-time
    Quality Systems Specialist – Medical Devices.Onsite 3 Days | Bay Area, CA | ~20% Travel.This role is critical to supporting, maintaining, and improving the. Quality Management System (QMS).Mai...Show moreLast updated: 8 days ago
    • Promoted
    Quality System Specialist (San Jose)

    Quality System Specialist (San Jose)

    CruxxSan Jose, CA, US
    Part-time
    Quality Systems Specialist Medical Devices.Onsite 3 Days | Bay Area, CA | ~20% Travel.This role is critical to supporting, maintaining, and improving the. Quality Management System (QMS).Maintain a...Show moreLast updated: 5 days ago
    • Promoted
    Quality System Specialist (Santa Clara)

    Quality System Specialist (Santa Clara)

    CruxxSanta Clara, CA, US
    Part-time
    Quality Systems Specialist Medical Devices.Onsite 3 Days | Bay Area, CA | ~20% Travel.This role is critical to supporting, maintaining, and improving the. Quality Management System (QMS).Maintain a...Show moreLast updated: 5 days ago
    • Promoted
    Quality Improvement Specialist

    Quality Improvement Specialist

    JLLMountain View, CA, US
    Full-time
    Quality & Audit Program Specialist.JLL empowers you to shape a brighter way.Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class ...Show moreLast updated: 20 days ago
    • Promoted
    Quality Improvement Specialist

    Quality Improvement Specialist

    University of California - San FranciscoSan Francisco, CA, United States
    Full-time
    Quality Improvement Specialist.The Quality Improvement Specialist will provide quantitative and qualitative programmatic and data analysis support to the clinical enterprises and its growing portfo...Show moreLast updated: 30+ days ago
    • Promoted
    Systems Operations Specialist

    Systems Operations Specialist

    ACCO Engineered SystemsPleasanton, CA, United States
    Full-time
    This position is responsible for providing administrative support including TAB Reports, Start-Up Reports, and Warranty Documents for the Systems Operations team. Essential Duties and Responsibiliti...Show moreLast updated: 17 days ago
    • Promoted
    Quality Control Manager (San Francisco)

    Quality Control Manager (San Francisco)

    Ground Up Construction RecruitingSan Francisco, CA, US
    Part-time
    Ground Up Construction Recruiting.They specialize in federal government, public works, and healthcare projects.The first project you'll start on is a $20M healthcare facility in Fairfield.Medical, ...Show moreLast updated: 5 days ago
    • Promoted
    Senior Quality Engineer (Hybrid) (San Francisco)

    Senior Quality Engineer (Hybrid) (San Francisco)

    iRhythm Technologies, Inc.San Francisco, CA, US
    Full-time +1
    Quality System Compliance activities, supporting equipment management, laboratory compliance and audit readiness at iRhythm Technologies. In this role, you will champion a quality culture mindset by...Show moreLast updated: 5 days ago
    • Promoted
    Software Quality Operations Specialist

    Software Quality Operations Specialist

    WaymoMountain View, CA, United States
    Full-time
    Waymo is an autonomous driving technology company with the mission to be the world's most trusted driver.Since its start as the Google Self-Driving Car Project in 2009, Waymo has focused on buildin...Show moreLast updated: 12 days ago
    • Promoted
    Senior Quality Systems Specialist

    Senior Quality Systems Specialist

    DanaherSunnyvale, CA, US
    Full-time
    Senior Quality Systems Specialist.At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Control Manager (San Francisco Bay Area)

    Quality Control Manager (San Francisco Bay Area)

    Ground Up Construction RecruitingSan Francisco Bay Area, US
    Part-time
    Ground Up Construction Recruiting.They specialize in federal government, public works, and healthcare projects.The first project you'll start on is a $20M healthcare facility in Fairfield.Medical, ...Show moreLast updated: 5 days ago