Jobs
>
Quality Engineer
>
Irvine

    Quality Engineer - Irvine, United States - TalentBurst, an Inc 5000 company

    TalentBurst, an Inc 5000 company
    TalentBurst, an Inc 5000 company Irvine, United States

    6 days ago

    Default job background
    Description

    Position: Quality Engineer I/II

    Location: Irvine, CA (100% onsite)

    Duration: 3 Months Contract

    Job Description:

    This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices. The role is not remote and will require a presence on campus.

    This opening is with the THV quality engineering team. The team of 23 engineers and technicians handles about 80 to 100 complaints per week. As a member of this team, you will have the opportunity to interact with domestic and global medical teams/clients.

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the client's systems/procedures for device investigation and risk assessments of reported complaints from the field.

    Education and Experience:

    • Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years of experience related to work experience required; or Master's Degree or equivalent in Engineering or Scientific field, 1 year experience including either industry or industry/education required.
    • Proficient with the Microsoft Office suite
    • Experience with medical device complaint investigations (CAPA's, NCR's, and Root-Cause Analysis)
    • Functional, physical, and visual testing of medical device equipment in a laboratory setting
    • Experience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
    • Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.
    • Preference is for candidates to have some complaint investigation experience/root cause analysis. Another preference is for medical device experience.

    Additional Skills:

    • Good documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills.
    • Basic understanding of statistical techniques
    • Previous experience working with lab/industrial equipment required
    • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
    • Solid problem-solving, organizational, analytical, and critical thinking skills
    • Solid understanding of processes and equipment used in assigned work
    • Knowledge of and adherence to Quality systems
    • Strict attention to detail
    • Ability to interact professionally with all organizational levels
    • Ability to manage competing priorities in a fast-paced environment
    • Must be able to work in a team environment, including the ability to manage project stakeholders
    • Ability to build productive internal/external working relationships

    Roles and Responsibilities:

    • Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
    • Perform hands-on device investigation using visual, dimensional, and test equipment to determine the root cause.

    Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.

    • Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determined by the investigation.
    • Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device-related issues.
    • Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).
  • Motion Recruitment

    Quality Engineer

    6 days ago

    Motion Recruitment Irvine, United States

    Title: Engineer-2 (Quality) · Location: Irvine, CA · Duration: Contract · About the Client: · Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitorin ...

  • Motion Recruitment

    Quality Engineer

    6 days ago

    Motion Recruitment Irvine, United States

    Title: Engineer-1 (Quality) · Location: Irvine, CA · Duration: Contract · About the Client: · Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitorin ...

  • TalentBurst, an Inc 5000 company

    Quality Engineer

    3 days ago

    TalentBurst, an Inc 5000 company Irvine, United States

    Position: Quality Engineer I (Complaint Investigations), Req#: 6086-1 · Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1 · Location: Irvine, CA (100% onsite) · Duration: 3 Months Contract · Job Description: · Education and Experience: · Bachelor's degree in ...

  • INTELLECTT INC

    Quality Engineer

    6 days ago

    INTELLECTT INC Irvine, United States

    Role: Quality Engineer · Location: Irvine, CA · Duration: 06+ Months on W2 · Job Description: · Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective a ...

  • Aequor Technologies

    Quality Engineer

    2 weeks ago

    Aequor Technologies Irvine, United States

    The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root ...

  • Motion Recruitment

    Quality Engineer

    5 days ago

    Motion Recruitment Irvine, United States

    Title: Engineer-2 (Quality) · Location: Irvine, CA · Duration: Contract · About the Client: · Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitorin ...

  • INTELLECTT INC

    Quality Engineer

    5 days ago

    INTELLECTT INC Irvine, United States

    poistion-Quality Engineer · Location: · Irvine, CA · Duration: · 3 Months · Job Description · This position will be in THV Quality Engineering, Global Product Surveillance (GPS). · The GPS team is responsible for leading and performing critical engineering investigations on ...

  • TalentBurst

    Quality Engineer

    6 days ago

    TalentBurst Irvine, United States

    Position: Quality Engineer I/II · Location: Irvine, CA (100% onsite) · Duration: 3 Months Contract · Job Description: · This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical enginee ...

  • End Point

    Quality Engineer

    4 days ago

    End Point Irvine, United States

    Endpoint is a digital title and settlement company built from the ground up to make home closing easy for all. For many, buying or selling a home is one of life's biggest transactions. At Endpoint, we help our customers close every deal so they can start their next chapter with c ...

  • Apartment Association of Orange County

    Quality Engineer

    2 days ago

    Apartment Association of Orange County Irvine, United States

    ABOUT US · Orchid Orthopedic Solutions · is world leading Medical Device Contract Design and Manufacturing company that offers a comprehensive portfolio of services for implants and instruments with significant experiencein the joint · reconstruction, spine, trauma, dental and ...

  • Pacer Staffing

    Quality Engineer

    6 days ago

    Pacer Staffing Irvine, United States

    Job Title: Quality Engineer · Location: · Irvine, CA · Duration: 12 months (Possibility of extension) · Key Responsibilities · Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all produc ...

  • Cynet Systems

    Quality Engineer

    6 days ago

    Cynet Systems Irvine, United States

    Pay range: $30 to $36.00Job Description:Qualifications: Planned, organize, and prioritize complaint investigation activities based on complaint closure and reportability timelines. Perform analysis in No Product Return Evaluations by utilizing multiple data inputs including techn ...

  • End Point

    Quality Engineer

    6 days ago

    End Point Irvine, United States

    Endpoint is a digital title and settlement company built from the ground up to make home closing easy for all. For many, buying or selling a home is one of life's biggest transactions. At Endpoint, we help our customers close every deal so they can start their next chapter with c ...

  • Baxter Healthcare Corporation

    Quality Engineer

    1 day ago

    Baxter Healthcare Corporation Irvine, United States

    This is where you save and sustain lives · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outc ...

  • Jabil

    Quality Engineer

    6 days ago

    Jabil Irvine, United States

    At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast networ ...

  • Jabil Malaysia

    Quality Engineer

    6 days ago

    Jabil Malaysia Irvine, United States

    At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast networ ...

  • INTELLECTT INC

    Quality Engineering

    1 week ago

    INTELLECTT INC Irvine, United States

    Role : Quality Engineering / Compliance Specialist · Location : Irvine, CA · Duration : 9 Months · Skills Looking For · Working on complaint evaluation for a medical device company · Responsibilities include intake, investigation, and summary writing for complaints · Basic co ...

  • Jnd Corp

    Engineering - Quality Engineer

    5 days ago

    Jnd Corp Irvine, United States

    Position OverviewJob Title: Engineering - Quality Engineer 3 Job Type: Regular Full-Time, HourlyBachelor's degree and related experience preferred LocationIrvine, CA BenefitsMedical Insurance (Health, Dental & Vision)401(k) with Company MatchPaid Time OffH1B/Green Card Sponsorshi ...

  • Katalyst HealthCares & Life Sciences

    Quality Engineer

    6 days ago

    Katalyst HealthCares & Life Sciences Irvine, United States

    Environment: · Our client is a large medical device manufacturer product manufacturer. · They are currently in need of several contractors to support a backlog of complaints that need to be remediated. · Responsibilities : · This consultant will come from a Medical Device bac ...

  • Camisasca Automotive Manufacturing

    Engineering & Quality Assurance Supervisor

    6 days ago

    Camisasca Automotive Manufacturing Lake Forest, United States

    **ABOUT US**: · - This is your opportunity to work with the finest automobile manufacturers in the world Come join our team of professionals in an established yet contemporary, family owned & operated company with 40 years' experience in quality parts manufacturing and global dis ...