Jobs
>
Andover

    Senior Design Quality Engineer - Andover, United States - TransMedics, Inc.

    TransMedics, Inc.
    TransMedics, Inc. Andover, United States

    4 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    JOB DESCRIPTION

    Position: Sr. Design Quality Engineer

    Reports to: Senior Director, Quality Assurance

    ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:

    • Responsible for the overall health of design control process. Responsible for assuring NPI and sustaining projects meet customer expectations, and regulatory requirements.
    • Partner with Development and Engineering departments and ensure that design control requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review
    • Provides input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures.
    • Review and approve design control related Change Notices (CNs) within the documentation system as applicable.
    • Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
    • Represent the design quality functions for the review and approval of designated design outputs.
    • Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).
    • Support the quality management system as required.
    • Perform other TransMedics task and duties as required.

    REQUIREMENTS:

    • BS in Engineering with 8 years of related experience or equivalent combination of education and experience.
    • Medical device development control experience required.
    • Working knowledge of Software development lifecycle desired.
    • Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 14971.
    • Practical knowledge and experience using Minitab or other statistical analysis tools.
    • Understanding and application of Gage R&R and Measurement System Analysis desired
    • Process validation experience including IQ/OQ/PQ desired.
    • Ability to communicate ideas and information clearly, effectively and concisely.
    • Highly detail oriented with strong organization and prioritization skills.

    EDUCATION:

    • BS in Engineering or other technical discipline
  • Lockheed Martin

    Site Quality Engineering Manager

    2 weeks ago

    Lockheed Martin Andover, United States

    **Job ID**: 665892BR · **Date posted**: May. 09, 2024 · **Description**:Lockheed Martin is seeking an experienced, highly motivated Quality Engineering Manager to lead the Quality Assurance organization at Lockheed Martin's cutting-edge Energy operations based in Andover, Massach ...

  • Lockheed Martin Corporation

    Site Quality Engineering Manager

    2 weeks ago

    Lockheed Martin Corporation Andover, United States

    **JOB ID**: 665892BR · **Date posted**: May. 09, 2024 · **Description**: · Lockheed Martin is seeking an experienced, highly motivated Quality Engineering Manager to lead the Quality Assurance organization at Lockheed Martin's cutting-edge Energy operations based in Andover, Mass ...

  • TransMedics

    Quality Engineer

    3 weeks ago

    TransMedics Andover, United States

    TransMedics, Inc. is a medical technology company that is transforming solid organ transplantation for patients with end-stage heart, lung, and liver failure. The Organ Care System (OCS), a first-in-class proprietary device/solution platform, was developed to improve quality, val ...

  • Energy Jobline CVL

    Quality Engineer

    3 weeks ago

    Energy Jobline CVL Andover, United States

    Principal People are currently working on behalf of a well-established, specialist manufacturing organisation who are looking for a Quality Engineer to join their team. · This role will be based near to Andover and this role will be responsible for undertaking company quality au ...

  • TransMedics

    Quality Engineer

    2 weeks ago

    TransMedics Andover, United States

    TransMedics, Inc. is a medical technology company that is transforming solid organ transplantation for patients with end-stage heart, lung, and liver failure. The Organ Care System (OCS), a first-in-class proprietary device/solution platform, was developed to improve quality, val ...

  • Bodycote

    Quality Engineer

    2 weeks ago

    Bodycote Andover, United States

    Quality Engineer Our people are the heart of our business. As the world's largest provider of thermal processing services, Bodycote employs thousands of highly skilled staff around the globe, some of the best engineers, scientists, and technicians in the industry. Our staff is e ...

  • Bodycote

    Quality Engineer

    2 weeks ago

    Bodycote Andover, United States Full time

    Our people are the heart of our business. · As the world's largest provider of thermal processing services, Bodycote employs thousands of highly skilled staff around the globe, some of the best engineers, scientists, and technicians in the industry. Our staff is encouraged to de ...

  • Spectrum Industries

    Quality Engineer

    21 hours ago

    Spectrum Industries Cambridge, United States

    Digital transformation. Sustainability. Peacekeeping. Exciting tasks that we at Diehl, in our five subgroups Metall, Controls, Defence, Aviation, and Metering, and our over employees are working on with high pressure. Discover fascinating technologies and apply now. In a family-o ...

  • TRIAD Engineering Corp

    Senior Quality Engineer

    1 week ago

    TRIAD Engineering Corp Andover, United States

    Our successful and well-established client is seeking a Senior Quality Engineer to join their growing team. In this role you will report directly to the Director of Process Engineering and will be a critical piece of the Operations Group. You will lead QA activities and technicia ...

  • TRIAD Engineering Corp

    Senior Quality Engineer

    3 weeks ago

    TRIAD Engineering Corp Andover, United States

    Our successful and well-established client is seeking a Senior Quality Engineer to join their growing team. In this role you will report directly to the Director of Process Engineering and will be a critical piece of the Operations Group. You will lead QA activities and technicia ...

  • Raytheon Technologies Corporation

    Operations Quality Engineer

    1 week ago

    Raytheon Technologies Corporation Andover, United States

    We are seeking a Hardware Quality Engineer with hands-on hardware quality experience to become a key part of Sensors Operations Quality organization. Here at Raytheon, our Operations Quality Team assures product and process quality with an emphasis o Quality Engineer, Operations, ...

  • Raytheon Technologies Corporation

    Senior Quality Engineer

    3 weeks ago

    Raytheon Technologies Corporation Andover, United States

    We are seeking a Senior Hardware Quality Engineer with hands-on hardware quality experience to become a key part of Operations Quality Advanced Electronic Assembly Team. Here at Raytheon, our Operations Quality Team assures product and process qual Quality Engineer, Quality, Engi ...

  • Raytheon Technologies Corporation

    Hardware Quality Engineer

    2 weeks ago

    Raytheon Technologies Corporation Andover, United States

    We are seeking a Hardware Quality Engineer with hands-on hardware quality experience to become a key part of Sensors Operations Quality organization. Here at Raytheon, our Operations Quality Team assures product and process quality with an emphasis o Quality Engineer, Hardware, Q ...

  • Rockstar Games

    Data Quality Engineer

    2 weeks ago

    Rockstar Games Andover, United States

    At Rockstar Games, we create world-class entertainment experiences. A career at Rockstar Games is about being part of a team working on some of the most creatively rewarding and ambitious projects to be found in any entertainment medium. You would be welcomed to a dedicated and i ...

  • Katalyst HealthCares & Life Sciences

    Sr Quality Engineer

    3 weeks ago

    Katalyst HealthCares & Life Sciences Andover, United States

    Responsibilities: · Lead problem solving teams for customer concerns and process improvement. · Lead the translation of customer expectations into plant processes and inspection techniques. · Lead cross functional teams for the timely and effective resolution of customer compl ...

  • Triad Engineering

    Senior Quality Engineer

    3 weeks ago

    Triad Engineering Andover, United States

    Our successful and well-established client is seeking a Senior Quality Engineer to join their growing team. In this role you will report directly to the Director of Process Engineering and will be a critical piece of the Operations Group. You will lead QA activities and technicia ...

  • Triad Engineering

    Senior Quality Engineer

    1 week ago

    Triad Engineering Andover, United States

    Our successful and well-established client is seeking a Senior Quality Engineer to join their growing team. In this role you will report directly to the Director of Process Engineering and will be a critical piece of the Operations Group. You will lead QA activities and technicia ...

  • Sloan

    Quality Engineer II

    5 days ago

    Sloan Andover, United States

    Req ID: 11225 Sloan is the world's leading manufacturer of commercial plumbing systems and has been in operation since 1906. We are at the forefront of the green building movement and provide sustainable restroom solutions. We manufacture water-efficient products including flush ...

  • Triad Engineering

    Senior Quality Engineer

    2 weeks ago

    Triad Engineering Andover, United States

    Our successful and well-established client is seeking a Senior Quality Engineer to join their growing team. In this role you will report directly to the Director of Process Engineering and will be a critical piece of the Operations Group. You will lead QA activities and technicia ...

  • TransMedics

    Manufacturing Quality Engineer

    3 weeks ago

    TransMedics Andover, United States

    If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. · Manufacturing Quality Engineer · Andover, MA, US · 7 days ago · Requisition ID: 1264 · JOB DESCRIPTION · Position · : ...