Talent.com
Quality Monitoring & Improvement Specialist I

Quality Monitoring & Improvement Specialist I

PenumbraAlameda, CA, United States
3 days ago
Job type
  • Full-time
Job description

As a key member of the Quality team, you will have a hand in ensuring that Penumbra's life-saving products adhere to the highest standards of quality and safety. In the Quality Monitoring & Improvement Specialist I role, you will be supporting our Quality Management System (QMS) processes, specifically Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NCRs) and Deviation Authorizations (DAs) following Penumbra's procedures and regulatory requirements. You will organize and host board meetings to facilitate board review of documentation supporting these systems. You will also assist with data compilation for monthly trending meetings.

What You'll Work On

  • Organizes and facilitates board meetings with guidance to review assigned QMS process documentation, giving regular status updates
  • Communicates with NCR / CAPA / DA owners to obtain status updates or provide reminders about upcoming due dates.
  • Maintains and updates NCR / CAPA / DA tracking systems.
  • Prioritizes routing QMS process documentation for approvals. Follows up with approvers if response is not received in a reasonable timeframe.
  • Collaborates and communicates cross-functionally with teams including, but not limited to, Manufacturing Engineering, Quality Engineering, Regulatory Affairs, R&D and Production.
  • Assists with data compilation for monthly trending meetings.
  • Receives data requests (charts, graphs, etc.), and implements the changes with

guidance / support.

  • Supports management during internal and external audits, with guidance / support.
  • Reviews quality records associated with the QMS process to ensure accuracy with the approved format and standards.
  • Provides basic guidance on the assigned QMS process(es).
  • Maintains control and access of quality records for the assigned QMS process.
  • Cross trains on other QMS processes and provides backup and support when needed.
  • What You Contribute

  • A Bachelor's degree preferably in engineering, life sciences, or a related field with 1+ years of quality systems experience in a regulated medical device or pharmaceutical environment, or an equivalent combination of education and experience.
  • Bilingual Spanish / English fluency is a plus
  • Medical device, pharmaceutical, biotech, or other regulated industry experience desired
  • Strong oral, written and interpersonal communication skills
  • High degree of accuracy and attention to detail
  • Proficiency with MS Word, Excel, and PowerPoint
  • Ability to create basic charts and graphs for data analysis in Excel
  • Excellent organizational, interpersonal, and verbal and written communication skills, with high attention to detail and the ability to deliver quality outputs under supervision.
  • Ability to excel in a fast-paced environment.
  • Working Conditions

    General office environments. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

    Base Pay Range Per Hour : $32.00 - 43.00 / hour

    Individual compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

    What We Offer

  • A collaborative teamwork environment where learning is constant, and performance is rewarded.
  • The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
  • A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
  • Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

    Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

    If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

    For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.

    Create a job alert for this search

    Quality Improvement Specialist • Alameda, CA, United States

    Related jobs
    • Promoted
    Quality Control Specialist I - Abstractor

    Quality Control Specialist I - Abstractor

    Public Health InstituteOakland, CA, United States
    Full-time +1
    If you are a current and active PHI employee, do not use this site to apply for positions.The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, ...Show moreLast updated: 2 days ago
    • Promoted
    Quality Improvement HC Specialist 4

    Quality Improvement HC Specialist 4

    University of California, San FranciscoSan Francisco, CA, United States
    Full-time
    Quality Improvement HC Specialist 4.The California Department of Public Health (CDPH), Office of AIDS (OA), Quality Improvement Health Care Specialist 4, provides highly specialized nurse consultat...Show moreLast updated: 3 days ago
    • Promoted
    Quality Improvement Specialist

    Quality Improvement Specialist

    Jones Lang LaSalle IP, Inc.Mountain View, CA, United States
    Full-time
    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 services, advisory and technology f...Show moreLast updated: 3 days ago
    • Promoted
    Quality Assurance Specialist I

    Quality Assurance Specialist I

    Abacus Service CorporationSouth San Francisco, CA, US
    Full-time
    Duration : 6 months - Onsite - Shift : M / F 2nd shift 1 : 30pm- 10pm - Education : High School - Temp To Hire : Yes.Basic Function : Responsible for auditing the products and processes at various points in...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Specialist, Quality Validation

    Specialist, Quality Validation

    AllerganSan Francisco, CA, United States
    Full-time
    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable i...Show moreLast updated: 4 hours ago
    • Promoted
    Quality Engineer II

    Quality Engineer II

    Bio-Rad LaboratoriesHercules, CA, United States
    Full-time
    The Bio-Rad Laboratories Design Quality Assurance team is seeking a detailed oriented Quality Engineer to support software life cycle management of life science and clinical diagnostics product des...Show moreLast updated: 30+ days ago
    • Promoted
    Service Process & Quality Specialist

    Service Process & Quality Specialist

    Bio-Rad LaboratoriesHercules, CA, United States
    Full-time
    Service Process & Quality Specialist.A typical day involves reviewing and updating Standard Operating Procedures (SOPs) to ensure compliance with 21CFR820 regulations, collaborating with product su...Show moreLast updated: 15 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
    Sr Specialist, Quality Systems

    Sr Specialist, Quality Systems

    GileadSan Mateo, CA, US
    Full-time
    At Gilead, we're creating a healthier world for all people.For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapie...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Quality Control Specialist

    Senior Quality Control Specialist

    Critical MassSan Jose, CA, US
    Full-time
    Senior Quality Control Specialist.As a Senior Quality Control Specialist, you are a strong communicator and trusted advisor who partners with Producers, Design Supervisors, Production Designers, St...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Manager

    Quality Manager

    Advantage ConvertingHayward, CA, US
    Full-time
    Advantage Converting is a dynamic and fast-paced manufacturing company with over 30 years of experience delivering high-quality components and engineered solutions to medical, electronics, green en...Show moreLast updated: 1 day 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: 12 days ago
    • Promoted
    Quality Systems Specialist

    Quality Systems Specialist

    Kelly Science, Engineering, Technology & TelecomSouth San Francisco, CA, United States
    Full-time
    Kelly® Science & Clinical is seeking a Quality Systems Scientist for.If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career...Show moreLast updated: 2 days ago
    • Promoted
    Senior Quality Specialist

    Senior Quality Specialist

    CCG Business SolutionsOakland, CA, US
    Full-time
    CCG Talent Management is not only a business solutions company but a company that believes success starts with the individual. CCG Business Solutions has been consulting and providing talent placeme...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Control Associate I

    Quality Control Associate I

    Canventa Life SciencesEmeryville, CA, US
    Full-time
    At Canventa Life Sciences, we strive to increase access to biologically relevant samples to researchers worldwide.Our team is again expanding our Quality Control team with a Quality Control Associa...Show moreLast updated: 1 day ago
    • Promoted
    Training and Quality Monitoring Associate

    Training and Quality Monitoring Associate

    Santa Clara Family Health PlanSan Jose, CA, United States
    Full-time
    Training and Quality Monitoring Associate.The expected pay range is based on many factors, such as experience, education, and the market. The range is subject to change.Manager, Customer Service Tra...Show moreLast updated: 30+ days ago
    • Promoted
    Quality & Training Specialist

    Quality & Training Specialist

    PeopleSuiteSan Francisco, CA, United States
    Full-time
    The Quality and Training Specialist plays a key role in driving customer retention, growth, and portfolio sales within the on-premise sector (Hotels, Restaurants, Bars and large businesses) across ...Show moreLast updated: 3 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