Jobs
>
Santa Ana

    Quality Engineer I - Santa Ana, United States - Artech

    Artech
    Artech Santa Ana, United States

    11 hours ago

    Default job background
    Description

    Job Title:
    Quality Engineer I

    Job ID:13605

    Location:1851 E. Deere Ave Santa Ana California Hybrid)

    Duration: 12 Months Contract


    Pay range:
    $40 -$45/hr on W2


    JOB DESCRIPTION
    Complaint Handling Specialist


    HM's Top Needs:

    • Experience in Complaint handling, complaint investigation and root cause analysis for Medical Devices
    • Ability to work cross-functionally, and deliver consistent outputs to meet set targets.
    • Strong knowledge of Cardiovascular diseases, use of heart valves and catheters
    Must Have

    Anatomy and physiology

    Complaint Handling

    Customer Complaint Investigations

    Highly proficient in Client Excel, Word, PowerPoint

    Medical device experience

    Root Cause Analysis

    Strong Communication Skills

    Technical Writing

    Nice To Have

    Complaint Trending

    Data Analysis

    Experience in Heart Valve Therapy

    Experience with Cardiovascular devices

    Heart disease states

    Risk Management


    Education Required:
    Bachelor s degree in Science/Engineering

    Years


    Experience Required:
    minimum 2 years

    Will the contractor be working 40 hours a week? If not, weekly estimate?

    40 hours

    Work Location:
    Do they need to be local to any MDT office and if so where?

    Yes, local to Santa Ana, CA or Orange County area

    Does this person need to be on site? If so, full time or part time?

    Flex i.e. part time on site.

    Responsibilities

    may include the following and other duties may be assigned.

    Conducts complaint investigations for Structural Heart devices.

    This includes performing intial assessment to create appropriate tasks or technical assessments in the Global Complaint Handling (GCH) system, for example - DHR reviews, Manufacturing assessment, R&D assessment ,etc.

    Performing thorough review of these assessments by working with the cross-functional teams (like Medical Safety, Manufacturing, Operations Quality, R&D, Design Assurance and Customer Quality Teams) across multiple sites and time zones globally.

    Summarizing the results of these assessment into the

    complaint investigation summary in a timely manner to ensure timely closure of the overall event.

    To be able to consistently close complaint investigations to meet weekly target volumes. Ensuring timely completion of complaint investigations to sustain a compliant timeliness metric/KPI for the entire Operating unit.

    Presenting complaints on a weekly basis and escalating events that meet certain criteria. To be able to communicate complaint information across all levels in the organization.


    Supporting regulatory submissions and regulatory inquries on complaints by working closely with Customer Quality Experience Management team (CQXM) and providing complaint data as requested.

    Ability to present the complaint investigation in an audit when needed.


    DIFFERENTIATING FACTORS

    Autonomy:
    Entry-level individual contributor on the post market quality team. Works with close supervision.

    Organizational Impact:
    Delivers work of limited scope, typically smaller, less complex projects or related activities.

    Innovation and Complexity:
    Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.

    Makes minor changes in systems and processes to solve problems.

    Communication and Influence:
    Communicates primarily with internal contacts across all levels within the operating unit.

    Contacts others to gather, confirm and convey information.

    Leadership and Talent Management:
    N / A

    job at this level is focused on self-development.

    Required Knowledge and Experience:
    Requires broad theoretical job knowledge typically obtained through advanced education.

    Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R.

    214.2(h)( 4)(iii)(A), 0 years of experience required.

    Thanks and regards

    Aniya shajan
    #J-18808-Ljbffr
  • Titan Ventures

    Quality Engineer

    4 days ago

    Titan Ventures West Park, United States

    Your roles and responsibilities · Quality assurance for multiple production processes · Quality pre-planning · Independent preparation and support of customer audits · Handling of complaints internally and externally · Workshop support · Moderation of process FMEA · Planning and ...

  • Orchid MPS Holdings, LLC

    Quality Engineer

    4 days ago

    Orchid MPS Holdings, LLC Santa Ana, United States

    ABOUT USOrchid 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 experience in the joint reconstruction, spine, trauma, dental and sports m ...

  • Orchid MPS Holdings, LLC

    Quality Engineer

    2 days ago

    Orchid MPS Holdings, LLC Santa Ana, United States

    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 experience in the joint · reconstruction, spine, trauma, dental and sports med ...

  • Orchid Orthopedics

    Quality Engineer

    4 days ago

    Orchid Orthopedics Santa Ana, 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 experience in the joint reconstruction, spine, trauma, dental and spor ...

  • RBC Bearings

    Quality Engineer

    4 days ago

    RBC Bearings Santa Ana, United States

    RBC Bearings Incorporated (NYSE: RBC/RBCP) is a leading international manufacturer of highly engineered precision bearings, components, and essential systems for the industrial, defense, and aerospace industries. Founded in 1919, the Company is primarily focused on producing high ...

  • Entegee

    Quality Engineer

    6 days ago

    Entegee Santa Ana, United States

    Job Description · Job DescriptionRequirements: · BS in Engineering · Experience in Complaint handling, investigation, and root cause analysis for Medical Devices · Knowledge of Cardiovascular diseases, heart valves, and catheters · Preferred Skills: · Ability to work cross-functi ...

  • The Timken Company

    Manager - Quality and Engineering

    6 days ago

    The Timken Company Los Alamitos, United States

    Personal and Professional Growth · Manager - Quality and Engineering · - Los Alamitos, CA, US, Your Career Begins at Timken · - If you're ready for a challenging career that provides you with the ability to advance personally and professionally, look to Timken. Our associates mak ...

  • Konnect Resources, LLC

    Quality Engineer

    2 days ago

    Konnect Resources, LLC Orange, United States

    Summary: The Quality Engineer is responsible for analyzing manufacturing planning to ensure compliance with customer specifications and evaluating outside suppliers to maintain quality standards. Additionally, they program and perform layout inspections of forged, machined, and f ...

  • Konnect Resources

    Quality Engineer

    4 days ago

    Konnect Resources Orange, United States

    Summary: The Quality Engineer is responsible for analyzing manufacturing planning to ensure compliance with customer specifications and evaluating outside suppliers to maintain quality standards. Additionally, they program and perform layout inspections of forged, machined, and f ...

  • Flag Solutions

    Quality Engineer

    1 week ago

    Flag Solutions Orange, United States

    Job Description · Job Description · JOB SUMMARY · Analyzes manufacturing planning to determine compliance with customer-required specifications and evaluates outside suppliers to ensure that quality standards are complying. · In addition, Programs and performs layout inspectio ...

  • Flag Solutions

    Quality Engineer

    5 days ago

    Flag Solutions Orange, United States

    Job Description · Job Description · Hello candidates, this is a 2-month contract position that can lead to a potential full-time position based on performance. If you are interested in a very hands-on experience, this will be the place for you to continue your career. For faste ...

  • InsulTech

    Senior Quality Engineer

    4 days ago

    InsulTech Santa Ana, United States

    Job Responsibilities · We are looking for a Quality Engineer to support our growing heat shield fabrication business. This is a great opportunity for someone who enjoys being out on the shop floor, solving problems in close collaboration with production staff. Specific tasks inc ...

  • InsulTech

    Senior Quality Engineer

    2 days ago

    InsulTech Santa Ana, United States

    Job Responsibilities · We are looking for a Quality Engineer to support our growing heat shield fabrication business. · This is a great opportunity for someone who enjoys being out on the shop floor, solving problems in close collaboration with production staff. · Specific task ...

  • TTM Technologies

    Quality Engineering Technician

    6 days ago

    TTM Technologies Santa Ana, United States

    TTM Technologies, Inc. - Publicly Traded US Company, NASDAQ (TTMI) - Top-5 Global Printed Circuit Board Manufacturer · About TTM TTM Technologies, Inc. is a leading global manufacturer of technology solutions including engineered systems, radio frequency ("RF") components and RF ...

  • Camisasca Automotive Manufacturing

    Engineering & Quality Assurance Supervisor

    4 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 ...

  • Design west Technologies

    Senior Quality Engineer

    4 days ago

    Design west Technologies Tustin, United States

    Design West Technologies Inc. of Tustin, CA has an immediate need for a full-time Senior Quality Engineer. The successful candidate will be responsible for providing quality interface and expertise within the business unit, establish and maintain quality management systems (ISO-9 ...

  • Valence

    Quality Engineer

    4 days ago

    Valence Garden Grove, United States

    Job OverviewReports to: Department SupervisorFLSA Status: Exempt Full-TimeLocation: Garden Grove, CAType: Full-TimeSchedule: 1st ShiftJob Summary:To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential f ...

  • Design West Technologies, Inc.

    Senior Quality Engineer

    4 hours ago

    Design West Technologies, Inc. Tustin, United States

    Job Description · Job DescriptionDesign West Technologies Inc. of Tustin, CA has an immediate need for a full-time Senior Quality Engineer. The successful candidate will be responsible for providing quality interface and expertise within the business unit, establish and maintain ...

  • Valence Surface Technologies

    Quality Engineer

    1 week ago

    Valence Surface Technologies Garden Grove, United States Full time

    Job Details · Description · Job Overview · Reports to: Department Supervisor · FLSA Status: Exempt Full-Time · Location: Garden Grove, CA · Type: Full-Time · Schedule: 1st Shift · Job Summary: · To accomplish this job successfully, an individual must be able to per ...

  • WestLAND Group, Inc.

    Quality Control Engineering Manager

    3 days ago

    WestLAND Group, Inc. Ontario, United States

    **Who We Are**: Voted one of the Best Firms to Work For and _Hot Firm_ by Zweig Group for multiple years. WestLAND Group, Inc. (WLG) is a full-service engineering, geospatial, land planning and utility locating firm providing creative and innovative solutions to public and privat ...