Current jobs related to MES Quality Engineer II - Elkton - Terumo Medical Corporation

  • MES Quality Engineer II

    2 days ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job SummaryThe MES Quality Engineer II position plays a critical role in ensuring the successful implementation of Manufacturing Execution System (MES) projects. This individual will work closely with cross-functional teams to ensure compliance and timely delivery of projects. The successful candidate will drive continuous improvement in production and...

  • MES Quality Engineer II

    1 week ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    {"Job Title": "MES Quality Engineer II", "Job Summary": "We are seeking a highly skilled MES Quality Engineer II to join our team at Terumo Medical Corporation. As a key member of our Quality Assurance team, you will be responsible for ensuring the compliance of our Manufacturing Execution System (MES) with regulatory requirements and industry standards.Your...

  • MES Quality Engineer II

    2 weeks ago

    Elkton, United States Terumo Medical Corporation Full time

    *We are not able to provide sponsorship for this role now or in the future. This also includes OPT. Greencard holders or US Citizens at this time*We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.​At...

  • Complaints Quality Engineer II

    1 week ago

    Elkton, Maryland, United States JBL Resources Full time

    Job Title: Complaints Quality Engineer IIWe are seeking a highly skilled Complaints Quality Engineer II to join our team at JBL Resources. As a Complaints Quality Engineer II, you will play a critical role in ensuring the highest standards of quality and regulatory compliance in our medical device manufacturing process.Key Responsibilities:Investigate and...

  • Complaints Quality Engineer II

    3 days ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job Title: Complaints Quality Engineer IIThe Complaints Quality Engineer II plays a crucial role in ensuring the quality and safety of medical devices by investigating and resolving customer complaints in a timely and efficient manner. This position requires strong analytical and problem-solving skills, as well as excellent communication and interpersonal...

  • Complaints Quality Engineer II

    4 days ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job Title: Complaints Quality Engineer IIThe Complaints Quality Engineer II plays a crucial role in ensuring the quality and safety of medical devices by investigating and resolving customer complaints in a timely and efficient manner. This position requires strong analytical and problem-solving skills, as well as excellent communication and interpersonal...

  • Complaints Quality Engineer II

    2 weeks ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job SummaryThe Complaints Quality Engineer II is a critical role within Terumo Medical Corporation, responsible for analyzing, evaluating, and investigating complaints received from external customers. This position requires a strong understanding of regulatory guidelines, including those set by the Food and Drug Administration (FDA), International Standards...

  • NPD Sr Engineer II

    1 month ago

    Elkton, United States Terumo Medical Corporation Full time

    Job SummaryThe NPD Senior Engineer II position is responsible for providing technical expertise, leadership and planning to a large or several smaller technical projects. The NPD Senior Engineer II uses their breadth of engineering knowledge and product development experiences to serve as a technical team leader providing engineering guidance, oversight and...

  • Complaints Engineer II

    2 months ago

    Elkton, United States Terumo Medical Corporation Full time

    The Complaints Engineer II is responsible for analyses, evaluation and product investigation of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR), EU MDR, and other regulatory guidelines....

  • Complaints Engineer II

    2 months ago

    Elkton, United States Terumo Medical Corporation Full time

    The Complaints Engineer II is responsible for analyses, evaluation and product investigation of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR), EU MDR, and other regulatory guidelines....

  • New Product Development Sr Engineer II

    4 weeks ago

    Elkton, United States Terumo Medical Corporation Full time

    Job Summary The NPD Senior Engineer II position is responsible for providing technical expertise, leadership and planning to a large or several smaller technical projects. The NPD Senior Engineer II uses their breadth of engineering knowledge and product development experiences to serve as a technical team leader providing engineering guidance, oversight and...

  • New Product Development Sr Engineer II

    2 months ago

    Elkton, United States Terumo Medical Corporation Full time

    Job SummaryThe NPD Senior Engineer II position is responsible for providing technical expertise, leadership and planning to a large or several smaller technical projects. The NPD Senior Engineer II uses their breadth of engineering knowledge and product development experiences to serve as a technical team leader providing engineering guidance, oversight and...

  • Senior NPD Engineer II

    3 weeks ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Position OverviewThe Senior NPD Engineer II role is pivotal in delivering technical leadership and strategic planning across multiple technical initiatives. This position leverages extensive engineering expertise and product development experience to guide a team of engineers, ensuring effective design and problem-solving throughout the product lifecycle.Key...

  • Senior NPD Engineer II

    3 weeks ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Position OverviewThe Senior Engineer II for New Product Development is tasked with delivering technical leadership, expertise, and strategic planning across multiple technical initiatives. This role leverages extensive engineering knowledge and product development experience to guide and mentor a team of engineers, ensuring effective problem-solving and...

  • Senior NPD Engineer II

    4 weeks ago

    Elkton, Maryland, United States Terumo Medical Corporation Full time

    Position OverviewThe Senior NPD Engineer II role is crucial for delivering technical leadership and strategic planning across multiple engineering projects. This position leverages extensive engineering expertise and product development experience to guide and mentor fellow engineers, ensuring effective technical solutions and project execution.Key...

  • Quality Engineer

    2 weeks ago

    Elkton, United States Actalent Full time

    Job Title: Complaints Quality Engineer Job Description Proactively investigate, identify, and implement best-in-class Quality Engineering practices. Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities. Establish effective corrective...

  • Quality Control Manager

    2 months ago

    Elkton, United States Terumo Medical Corporation Full time

    The Manager, Quality Control is responsible for managing quality operations functions within the respective manufacturing facility. S/he is responsible for ensuring compliance with the applicable regulations of all countries in which Terumo Medical either manufactures or distributes products including, but not limited to the U.S. Quality System Regulation,...

  • Quality Control Manager

    2 months ago

    Elkton, United States Terumo Medical Corporation Full time

    The Manager, Quality Control is responsible for managing quality operations functions within the respective manufacturing facility. S/he is responsible for ensuring compliance with the applicable regulations of all countries in which Terumo Medical either manufactures or distributes products including, but not limited to the U.S. Quality System Regulation,...

  • NPD Design Engineer II

    1 month ago

    Elkton, United States Terumo Medical Corporation Full time

    Job SummaryThe NPD Engineer 2 position is responsible for providing technical expertise, leadership and planning to smaller projects. The NPD Engineer 2 is typically a technical team member. The NPD Engineer II Design Engineer position is specifically accountable for the product design, development, and technical problem solving. This position executes the...

  • Manufacturing Quality Engineer

    4 months ago

    Elkton, United States Terumo Medical Corporation Full time

    ***We are not offering sponsorship right now. This includes individuals on OPT, unfortunately we are not able to move forward***We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.​At Terumo we believe...

MES Quality Engineer II

4 months ago

Elkton, United States Terumo Medical Corporation Full time

Job Summary:

The Manufacturing Execution System (MES) Quality Engineer II position will work closely with the IT, Operations, Validation, and Engineering, teams to ensure that projects (new MES deployments, sustaining, and/or optimization) related to MES are implemented compliantly and in a timely manner. This role will support production to drive continuous improvement. The position will also ensure compliance to Terumo’s quality policy, develop requirements, revise/create procedures, develop validation test cases, and maintain the integrity of the electronic device history record (eDHR).

Job Details:

  1. Act as an integrated MES team member to support new MES deployments, sustaining, and optimization projects
  2. Demonstrates understanding and application of engineering principles on cross-functional projects
  3. Develop and/or revise MES requirements documentation, procedures, control plans, PFMEAs, and training materials
  4. Maintain the compliance of the MES, the integrity of its validated state, and the eDHR
  5. Proactively identifies requirements gaps, investigates, and implements best-in-class Quality Engineering practices and solutions
  6. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues related to MES
  7. Develop MES validation test cases and support Software Verification & Validation activities
  8. Support the Elkton, MD site as a subject matter expert (SME) related to MES and the integration with Product Life Cycle Management
  9. Develop training strategy plans and support MES team to deliver training on MES processes
  10. May need to work across shifts during some phases of MES deployments
  11. Perform other job-related duties

Position Requirements:

Knowledge, Skills and Abilities (KSAs)

· Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC

· Excellent communication skills; verbal and written

· Ability to work as a team member on cross-functional teams and with employees across

all levels within the facility

· Excellent computer skills and working knowledge of Microsoft Office Suite

· Problem-solving and critical thinking

· Detail and results-oriented

· Self-motivated and driven

· Ability to multitask, prioritize, and provide deliverables within the required timeframe

· Excellent organizational and time management skills

Background Experiences

· Requires Bachelor’s degree (4 years) or higher from an accredited course of study, in engineering, engineering technology, computer science or technical field with relevant experience

· Requires at least three (3) years experiences in a medical device or highly regulated industry

· Experience working in a manufacturing environment preferred

· Experience with implementing and maintaining a Manufacturing Execution System / eDHR preferred

· Experience with Change Management, Computer System Validation, and HP ALM preferred