Jobs
>
Newport Beach

    Quality Systems Engineer - Newport Beach, United States - Cathworks

    Cathworks
    Cathworks Newport Beach, United States

    3 weeks ago

    Default job background
    Description
    Job Description


    Job Description Salary:


    CathWorks, with offices in Israel, USA, Japan, and the Netherlands, is a fast-paced medical device start-up focused on digital health innovations to improve the lives of patients globally.

    The CathWorks FFRangio System combines artificial intelligence (AI) and computational science to provide physicians with comprehensive physiologic information, enabling them to make better treatment decisions for their patients with coronary artery disease.

    Recently, CathWorks entered into a strategic partnership with Medtronic to market and sell the FFRangio System globally.

    Medtronic is the global leader in medical technology and has more than 90,000 employees worldwide in more than 150 countries.

    The partnership with Medtronic will expand CathWorks' footprint globally, enabling more patients to benefit from its revolutionary technology that is poised to disrupt the current coronary physiology market.


    As a Quality Systems Engineer at CathWorks, you will play a pivotal role in supporting and ensuring the quality and compliance of our products and processes.

    Your responsibilities will encompass various aspects of quality assurance, including documentation management, training oversight, and process maintenance.

    This role is crucial for maintaining the high standards of quality that are integral to CathWorks' mission of improving the lives of patients through innovative healthcare solutions.


    Job Description:

    Quality System Management:
    Maintain and enhance quality system activities to align with QA department goals.
    Report on system performance, initiating and leading quality improvement actions.
    Assist in writing and updating procedures for regulatory compliance, including ISO13485: 2016 and USA 21 CFR§820.


    Quality Process Oversight:
    Participate in the maintenance and improvement of quality processes like MRBs, CAPA, failure investigations, and customer complaint handling.
    Manage the US complaint intake process, working with field associates and investigation teams.
    Summarize complaint investigation findings for customer communication.
    Initiate, manage, and create action plans for CAPAs and MRBs, collaborating with the product team for MRB dispositions.
    Analyze key data for trends in CAPA/MRB and complaints.


    Document and Training Management:


    Provide US support for LMS/DMS, including document revisions and approvals, ensuring proper management of controlled documents on platforms like Showpad and SharePoint.

    Oversee training aspects using our QMS (Simploud): manage overdue training items, create new-hire training plans, lead annual company-wide and individual onboarding quality training, and set the annual US training plan.


    Vendor and Logistics Coordination:
    Manage documentation control and oversee the approved supplier list.

    Act as the primary contact for managing third-party logistics and operations vendors, including sales team coordination and handling sales quality complaints.

    Lead and manage third-party logistics vendors, ensuring adherence to safety, quality, delivery, and cost metrics. Perform on site audits according to the QA audit plan.
    Maintain the device DHR in the electronic system, review and approve installation files and service reports


    Compliance and Continuous Improvement:
    Ensure that all Commercial Operations' programs and processes remain compliant with applicable laws and regulations.

    Collaborate cross-functionally with internal and external partners to develop strategies, meet the company's strategic objectives, and uphold quality standards while improving operational efficiency.

    Support and contribute to both internal and external audits.
    Monitor conformance to both domestic and international standards and regulations.
    Engage in projects aimed at maintaining and improving the Quality System in accordance with national and international standards.

    Required


    Qualifications/Skills:
    Bachelor's degree in a related discipline or equivalent work experience.
    5-10 years experience in Quality Assurance or a related field, with knowledge of quality systems.
    Excellent written, verbal, and presentation skills with a strict attention to detail.
    Strong organizational skills, time management skills, and ability to manage competing priorities in a fast-paced environment.

    Ability to work with teams across our organization and adapt to working with team members in different time zones and locations.

    Proficiency in using quality management systems and software.

    #J-18808-Ljbffr
  • Stellar Enterprises

    Systems and Requirements Engineer

    2 weeks ago

    Stellar Enterprises Long Hill, United States

    As a Systems and Requirements Engineer (m/f/d) - E-Mobility at Long Hill, you will act as a technology and trend scout in the field of high-voltage (HV) drivetrains, as well as for current and evolving vehicle electrical architectures and topologies. We are looking for an HV expe ...

  • Anduril Industries

    Systems Engineer

    2 weeks ago

    Anduril Industries Costa Mesa, CA, United States

    Anduril Industries is a defense technology company with a mission to transform U.S · and allied military capabilities with advanced technology · By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Andu ...

  • BlueWing Ventures, LLC.

    Systems Engineer, Land Systems

    2 weeks ago

    BlueWing Ventures, LLC. Costa Mesa, United States

    WHY WE'RE HERE: · Anduril's Land Systems team is seeking a Systems Engineer to join our team. The Land Systems team at Anduril develops software for land-based robotic systems, leveraging software infrastructure built by other Anduril product teams. The team is responsible for t ...

  • Anduril

    Systems Engineer

    1 week ago

    Anduril Costa Mesa, United States Full time

    · Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, And ...

  • Anduril

    Systems Engineer

    2 days ago

    Anduril Costa Mesa, United States Full time

    · Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, And ...

  • Bowman Williams

    Senior System Engineer

    2 weeks ago

    Bowman Williams Newport Beach, United States

    We are a leading Cloud/Managed Services Provider, focused on cutting edge that allows our clients to prosper and grow. We have a reputation for building robust, high-performing, customized cloud solutions with the reliability and responsiveness that providers can trust. We emphas ...

  • Bowman Williams

    Senior System Engineer

    2 weeks ago

    Bowman Williams Newport Beach, United States

    Senior System Engineer – Managed Services Team · Senior System Engineer – Managed Services Team · Senior System Engineer – Managed Services Team · We are a proactive Cloud and IT services company servicing the local businesses for 2+ decades. We have been growing consistently b ...

  • Bowman Williams

    Senior System Engineer

    1 week ago

    Bowman Williams Newport Beach, United States

    We are a leading Cloud/Managed Services Provider, focused on cutting edge that allows our clients to prosper and grow. We have a reputation for building robust, high-performing, customized cloud solutions with the reliability and responsiveness that providers can trust. We emphas ...

  • Bowman Williams

    Senior System Engineer

    1 week ago

    Bowman Williams Newport Beach, United States

    We are a leading Cloud/Managed Services Provider, focused on cutting edge that allows our clients to prosper and grow. We have a reputation for building robust, high-performing, customized cloud solutions with the reliability and responsiveness that providers can trust. We emphas ...

  • anduril

    Systems Security Engineer

    3 weeks ago

    anduril Costa Mesa, United States

    Systems Security Engineer - Active Clearance · Anduril · Transforming US & allied military capabilities with advanced technology. · View company page · Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with ad ...

  • Anduril Industries

    Fuel Systems Engineer

    1 week ago

    Anduril Industries Costa Mesa, CA, United States

    Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Anduri ...

  • Anduril Industries

    Fuel Systems Engineer

    1 week ago

    Anduril Industries Costa Mesa, United States

    Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Anduri ...

  • Anduril

    Fuel Systems Engineer

    1 week ago

    Anduril Costa Mesa, United States Full time

    · Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, And ...

  • Anduril Industries

    Systems Security Engineer

    1 week ago

    Anduril Industries Costa Mesa, United States

    Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Anduri ...

  • BlueWing Ventures, LLC.

    Systems Security Engineer

    3 weeks ago

    BlueWing Ventures, LLC. Costa Mesa, United States

    Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Anduri ...

  • Anduril Industries

    Systems Security Engineer

    3 weeks ago

    Anduril Industries Costa Mesa, United States

    At Anduril we are developing cutting-edge artificial intelligence systems, command and control platforms, aerospace vehicles, and long range sensors. We are looking for systems security engineers with experience in these fields to help design and manage the security posture of th ...

  • Experian, plc

    Systems Engineer Lead

    2 weeks ago

    Experian, plc Costa Mesa, United States

    Architecting complex technical Cloud CRM solutions; Integrating multiple cloud and premise based technologies with platform; Architecting, designing, and developing advanced customizations utilizing and Force. Systems Engineer, Systems, Salesforce, Engineer, Lead, Technology · ...

  • Anduril Industries

    Fuel Systems Engineer

    2 weeks ago

    Anduril Industries Costa Mesa, United States

    Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st centurys most innovative companies to the defense industry, Anduril ...

  • Experian Health

    Systems Engineer Lead

    2 weeks ago

    Experian Health Costa Mesa, United States

    Job Posting - Salary Range: $107,024 - $192,644 · Department: Product Development · Schedule: Full Time · Company Description · MyExperian Inc. is the world's leading global information services company. During life's big moments – from buying a home or a car, to sending a child ...

  • Anduril Industries

    Fuel Systems Engineer

    2 weeks ago

    Anduril Industries Costa Mesa, United States

    Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st centurys most innovative companies to the defense industry, Anduril ...