Jobs
>
Doral

    Design Assurance Engineer - Doral, United States - Compunnel

    Compunnel
    Compunnel Doral, United States

    1 week ago

    Default job background
    Description

    Title:
    Development Quality Engineer


    Location:
    Miami FL 33196

    Duration: 12 months Contract


    Description:
    The Staff Development Quality Engineer supports new product development (instruments, reagents, consumables, and software) from a QA perspective.

    The primary role of the position is to provide guidance and direction to cross functional core teams to meet design control requirements in support of market release of new products.

    The position also supports post-launch design changes for fielded products.


    RESPONSIBILITIES:

    • Provide strategic direction for new product development and design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, post-market quality and risk management.
    • Ensure proactive compliance to all applicable internal, domestic and international regulations including US 21 CFR 820 (QSR), ISO 19471:2019 and ISO 13485:2016.
    • Ensure compliant and complete product documentation, inclusive of DHFs, with particular focus on design controls, risk management and document controls.
    • Lead extended Quality teams for new product development and design change projects.
    • Review and approve design and development documentation including Design Development plans, Design Change plans, User Needs, Design Input and Design Output documents, Design Verification Protocols and Reports, Design Validation Protocols and Reports, Software Requirement documents and associated Software Verification test procedures and reports, and System Risk Assessment documentation.
    • May review and approve engineering drawings, specifications, procedures, engineering changes, and manufacturing work instructions, etc.
    • Assures that newly developed products are successfully transferred into the supply chain including manufacturing and service environments.
    • Participates in Design Reviews and develop, approve, and review associated documentation.
    • Responsible for Design History File (DHF) completeness and maintenance.
    • Utilize problem solving techniques ad take a broad perspective to identify innovative solutions.
    • Interact frequently with other functional areas and operating entities which requires specialized depth and/or breadth of expertise.

    QUALIFICATIONS:

    • Bachelor's degree in engineering or science discipline with seven years of experience in a regulated environment or master's degree in engineering or science discipline with five years of experience in a regulated environment.
    • Experience in application of design controls in accordance with 21 CFR Part 820, ISO 13485, and ISO 9001 for the development of products and design change.
    • High level of autonomy and critical thinking is required. Teamwork oriented.
    • Must be able to multi-task and prioritize in a fast-paced environment.
    • Must have strong verbal and written communication skills and be capable of producing detailed and comprehensive quality system documentation and reports.
    • Computer skills (MS Office products).
    • ASQ Certified Quality Engineer (CQE) is preferred.
    #J-18808-Ljbffr
  • Sunrise Systems

    Quality Assurance Engineer

    2 weeks ago

    Sunrise Systems Doral, United States

    Our client, a leading medical devices company, is looking for a · Quality Assurance Engineer. · This is for an initial duration of · 7 months · and is located in · Miami, FL · Responsibilities: · strategic direction for design change teams in terms of quality functions incl ...

  • InterEx Group

    Quality Assurance Engineer

    2 weeks ago

    InterEx Group Doral, United States

    Job Description: · Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity · We are seeking a highly skilled and experienced Quality Engineer to join our team. The ideal candidate will have a minimum of 2 years of exper ...

  • Primary Talent Partners, Inc.

    Quality Assurance Engineer

    2 weeks ago

    Primary Talent Partners, Inc. Doral, United States

    Primary Talent Partners has an exciting opportunity with our client in the Miami, FL area. This is a contract position with a duration of 7 months and possibility for extension or conversion. · No C2C candidates will be considered at this time. · Pay Range: $41/hr - $46/hr · S ...

  • Compunnel

    Design Assurance Engineer

    2 weeks ago

    Compunnel Doral, United States

    Title: Development Quality Engineer · Location: Miami FL 33196 · Duration: 12 months Contract · Description: · The Staff Development Quality Engineer supports new product development (instruments, reagents, consumables, and software) from a QA perspective. The primary role of ...

  • Vivex Biomedical , Inc.

    Quality Assurance Engineer I

    2 weeks ago

    Vivex Biomedical , Inc. Doral, United States

    Job purpose · The Quality Assurance Engineer develops, applies, revises, and maintains quality metrics to support areas of operations at Vivex Biologics, Inc. The role assists in the planning, development, implementation, communication, and maintenance of Vivex's quality manageme ...

  • LeadStack Inc.

    Senior Quality Assurance Engineer

    2 weeks ago

    LeadStack Inc. Doral, United States

    Job title: Quality Assurance Engineer- (Senior) · Location: Miami FL 33196 · Duration: 7 months · PR: $35/hr - $46/hr on W2 · Key Responsibilities: · • Provide strategic direction for design change teams in terms of quality functions including design quality, manufacturing quali ...

  • Insight Global

    Remote Manual Quality Assurance Engineer

    4 weeks ago

    Insight Global Doral, United States

    Position: Remote Manual QA Engineer · Location: Broomfield, CO · Duration: 6 Month Contract (Perm possible) · Salary range: $97,760-$110,240 · Requirements: · - 6+ years of experience with all aspects of the QA lifecycle in an enterprise environment (test plans, test scripts, te ...

  • InterEx Group

    Quality Assurance Engineer

    3 weeks ago

    InterEx Group Miami, United States

    Job Description: · We are seeking a highly skilled and experienced Quality Engineer to join our team. The ideal candidate will have a minimum of 2 years of experience programming Zeiss CMM with Calypso, as well as expertise in various quality assurance processes including Seleniu ...

  • Compunnel, Inc.

    Senior Quality Assurance Engineer

    3 weeks ago

    Compunnel, Inc. Miami, United States

    Job Description · Job Description · DescriptionRESPONSIBILITIES:Provide strategic direction for design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, post-market quality and risk management.Ensure ...

  • Trividia Health

    Supplier Quality Assurance Engineer

    5 days ago

    Trividia Health Fort Lauderdale, United States

    *Please note this position is Monday - Friday onsite located in Ft. Lauderdale, FL* · SUMMARY · Individual is responsible for the investigation, analysis and the resolution of supplier quality problems by conducting audits, analyzing defect trends and participating in continuou ...

  • Trividia Health

    Supplier Quality Assurance Engineer

    2 weeks ago

    Trividia Health Fort Lauderdale, United States

    *Please note this position is Monday - Friday onsite located in Ft. Lauderdale, FL * · SUMMARY · Individual is responsible for the investigation, analysis and the resolution of supplier quality problems by conducting audits, analyzing defect trends and participating in continuo ...

  • Trividia Health

    Supplier Quality Assurance Engineer

    1 week ago

    Trividia Health Fort Lauderdale, United States

    *Please note this position is Monday - Friday onsite located in Ft. Lauderdale, FL * · SUMMARY · Individual is responsible for the investigation, analysis and the resolution of supplier quality problems by conducting audits, analyzing defect trends and participating in continuo ...

  • Brave Health

    Senior Software Quality Assurance Engineer

    19 hours ago

    Brave Health Miami, United States

    Job Description · Job DescriptionAbout Us: · Nearly 1 in 4 people in the U.S. get their healthcare coverage through Medicaid, but nearly two thirds of psychiatrists don't accept Medicaid. This gap has only grown larger over time, creating a clear opportunity for a model that deli ...

  • Infinity Systems

    Project Manager for Substations

    3 weeks ago

    Infinity Systems Westwood Lakes, United States

    At Westwood Lakes, we are looking for experts like you who are ready to take technologies to the next level, tackle challenges, and work on the innovations of tomorrow: · This will be your future job · Responsibility for the construction and renovation of substations up to 110 kV ...

  • Continental Services Group

    Quality Assurance Lead

    3 weeks ago

    Continental Services Group Miami, United States

    **Drive Regulatory Compliance and Quality Excellence in biologicals for In-Vitro, Diagnostics and Research** · **Company Overview**: · **Position Overview**: · We are seeking an experienced Quality Assurance Lead to ensure the highest standards of quality, regulatory compliance, ...

  • Verify Inc.

    Source Inspector

    3 weeks ago

    Verify Inc. North Miami, United States

    Overview: · **Industry: Aerospace/Defense** · **Position: Source Inspector** · **Location: North Miami, Florida** · **Duration: 3 month contract** · **Frequency: up to 40/hrs per week - full-time - W2** · **Pay rate: $28.00 to $30.00 per hour** · - Perform source inspections requ ...

  • Ttg Talent Solutions

    Plumbing Designer

    1 week ago

    Ttg Talent Solutions Florida-Miami, Florida, United States

    Plumbing Designer · Miami, FL · Mon-Fri · Overview: We are seeking a highly skilled and creative Plumbing Designer to join our dynamic team. As a Plumbing Designer, you will be responsible for designing efficient and innovative plumbing systems for various commercial and resident ...

  • The State of Florida

    Project Development Supervisor Ii

    3 weeks ago

    The State of Florida Miami, United States

    Requisition No: 828678 · Agency: Department of Transportation · Working Title: PROJECT DEVELOPMENT SUPERVISOR II · Pay Plan: SES · Position Number: · **Salary**: $93, $120,562.16 · Posting Closing Date: 05/24/2024 · **Total Compensation Estimator **Tool** · **STATE OF FLORIDA D ...

  • The Walsh Group

    Commercial Manager

    3 weeks ago

    The Walsh Group Miami, United States

    Overview: · Archer Western, a member of The Walsh Group, is currently seeking a **Commercial **Manager **at our **Miami Signature Bridge Project** located in **Miami, FL**. · Are you someone who trusts your instincts and has confidence in your ability as a leader? When you see po ...

  • MasTec Utility Services

    Operations Manager

    2 weeks ago

    MasTec Utility Services Miami, United States

    Overview: · **Company Summary** · **MasTec Utility Services** delivers critical infrastructure construction and engineering services for power delivery, gas, and water customers, specializing in overhead and underground electric distribution for power delivery systems, gas distri ...