Senior Quality Systems Engineer

3 hours ago


Elkton, Minnesota, United States Terumo Medical Corporation Full time
Job Title: Senior Quality Systems Engineer

Terumo Medical Corporation is seeking a highly skilled Senior Quality Systems Engineer to join our team. As a key member of our Quality Systems department, you will be responsible for ensuring compliance with global Quality System regulations and driving our efforts to maintain a robust and effective Quality Management System.

Key Responsibilities:
  • Support the management and effectiveness of the Quality Management System, primarily the CAPA system
  • Provide guidance to CAPA Teams and participate on CAPA Teams as needed
  • Review and approve corrective and preventive action plans, implementation of required activities, and effectiveness verification
  • Teach and mentor CAPA owners on root cause analysis and technical writing
  • Establish and maintain CAPA process metrics and lead activities related to the CAPA Board
  • Work with Organizational Stakeholders to ensure CAPA and other quality system requirements are well understood and appropriately incorporated into CAPA documentation and Management Review
  • Generate Quality System Standard Operating Procedures and develop Quality System training materials
  • Contribute to the development of Quality System performance measures and lead third-party audit activities as required
Requirements:
  • Demonstrated knowledge in 21 CFR Part 820, ISO 13485:2016, Medical Device Directive / Regulation
  • Strong computer knowledge (MS Office), technical writing skills, and proofreading ability
  • Advanced skill in developing and maintaining spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports
  • Demonstrated ability to lead a group of participants from problem statement, root cause identification, and verification of effectiveness
  • Demonstrated ability to interact with all levels of management, co-workers, and regulators
  • Must possess strong decision-making and prioritization skills, as well as strong written, verbal, and interpersonal communication skills
Background Experiences:
  • Position requires a 4-year degree in engineering or a scientific discipline or equivalent combination of education and work experience
  • Minimum 8 years' experience in a Quality Engineering, Compliance, or other related Quality System role(s) in a medical device or pharmaceutical company
  • Experience performing root cause analysis/investigations, supporting a regulated manufacturing operation, and working with electronic quality system tools
  • Six Sigma Black/Green Belt Certification and ISO 13485 Lead Auditor Certification are preferred

Terumo Medical Corporation is an equal opportunity employer and welcomes applications from diverse candidates. We value diversity of background and opinion and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination, or any other terms and conditions of employment.



  • Elkton, Minnesota, United States Actalent Full time

    Job Title:Product Systems EngineerJob Description:The Product Systems Engineer is responsible for ensuring a structured and interdisciplinary development approach for product systems from concept to production. This role considers both the business and technical needs of all customers to provide a quality product that meets user needs.As the technical...


  • Elkton, Minnesota, United States Terumo Medical Corporation Full time

    Job SummaryThe Sr. Engineer I - Process Engineering position is responsible for providing advanced engineering support to existing product process transfer projects, process improvements/cost reduction activities affecting the form, fit or function of the product, and new product development process and production equipment development requirements in...


  • Elkton, Minnesota, United States Innova Solutions Full time

    Job Description:The Quality Specialist will play a crucial role in supporting manufacturing operations by becoming familiar with site processes, procedures, and policies. This individual will develop knowledge aligned with cGMPs and Health Authority regulations, ensuring compliance and quality standards are met.Key Responsibilities:Support the review and...

  • Welding Engineer

    7 days ago


    Elkton, Minnesota, United States Autokiniton Full time

    Job Title: Welding EngineerAt Autokiniton, we are seeking a skilled Welding Engineer to join our team. As a key member of our production team, you will be responsible for ensuring the quality and efficiency of our welding processes.Key Responsibilities:Maintenance floor support on all welding equipment, including programming, weld integrity, cut and etch...


  • Elkton, Minnesota, United States Michael Page Full time

    Job Title: Global Automation EngineerMichael Page is seeking a highly skilled Global Automation Engineer to join their team. As a key member of the global virtual team, you will play a crucial role in standardizing and digitalizing processes across the company's sites.About the RoleThis exciting opportunity offers a challenging and rewarding experience in...


  • Elkton, Minnesota, United States eTeam Full time

    Job Title: Chemical EngineerWe are seeking a highly skilled Chemical Engineer to join our team at eTeam. As a key member of our Process Development department, you will play a crucial role in the development and optimization of our bioprocesses.Key Responsibilities:Participate in the design, development, and optimization of fermentation and purification...


  • Elkton, Minnesota, United States PLC Paramedics Full time

    Field Service Controls Engineer/Programmer Job DescriptionThis is an exciting opportunity to work with a well-established business that has a long history of providing field service and support to its customer base. As a Field Service Controls Engineer/Programmer, you will be a key part of our team, responsible for performing field service and designing,...


  • Elkton, Minnesota, United States MasterTech Full time

    Diesel Truck Technician OpportunityWe are seeking a skilled Diesel Truck Technician to join our team at MasterTech in Elkton, MD. As a Diesel Truck Technician, you will be responsible for performing routine maintenance and repairs on diesel trucks, ensuring they are in top working condition.Key Responsibilities:Perform routine maintenance tasks, such as oil...


  • Elkton, Minnesota, United States W L Gore and Associates, Inc Full time

    About the RoleWe are seeking a highly skilled Maintenance Coordinator to join our Maintenance Team. The successful candidate will support the Local Maintenance Leader by analyzing data, summarizing information, providing associates with organizational information, keeping leaders informed, measuring results, proposing action plans, maintaining an efficient...


  • Elkton, Minnesota, United States Christiana Care Full time

    Job SummaryChristianaCare is seeking a skilled CT Technologist to join our team in Elk Mills, Maryland.Key ResponsibilitiesPerform CT scans and other diagnostic imaging exams as skills permitVerify insurance pre-authorization and administer contrast media under physician's supervisionAssist in the learning process of students and new staff in department...


  • Elkton, Minnesota, United States Net2Source Inc. Full time

    Job Title: Environmental Monitoring TechnicianNet2Source Inc. is a leading provider of total workforce solutions, recognized for our accelerated growth and global presence. We are seeking a skilled Environmental Monitoring Technician to join our Quality Operations team.Job Summary:The Environmental Monitoring Technician will be responsible for monitoring...

  • Nurse Practitioner

    3 days ago


    Elkton, Minnesota, United States Christiana Care Full time

    Job Title: Registered Nurse - PCUChristianaCare is seeking a skilled Registered Nurse to join our Progressive Care Unit (PCU) team. As a PCU nurse, you will provide high-quality patient care to acutely ill adult patients, utilizing your critical thinking and clinical expertise to assess, plan, and deliver individualized care.About the Role:Provide direct...

  • EMT-B Driver

    6 hours ago


    Elkton, Minnesota, United States All American Ambulance and Transport Full time

    Job Title: EMT-B DriverJoin All American Ambulance and Transport as an EMT-B Driver and be part of a team that provides high-quality patient care and transportation services.Job Summary:We are seeking a skilled and compassionate EMT-B Driver to join our team. As an EMT-B Driver, you will be responsible for operating emergency vehicles, transporting patients,...


  • Elkton, Minnesota, United States Manufacturing Operations Full time

    Job SummaryMaintain the optimal performance of injection molding machines, molds, and extrusion lines through troubleshooting, emergency maintenance, and scheduled preventive maintenance. Perform mold changes, hang molds, and complete changeovers. Obtain spare parts and technical information for spare parts. Work under general supervision to receive...

  • Nurse Specialist

    4 days ago


    Elkton, Minnesota, United States ChristianaCare Full time

    Job Title: Registered Nurse (RN) - Float Pool TeamChristianaCare is seeking a skilled Registered Nurse (RN) to join our Float Pool Team at Union Hospital in Elkton, Maryland.About the Role:As a Float Pool RN, you will work in various units, providing high-quality patient care and developing valuable skills.Our team is committed to delivering exceptional...


  • Elkton, Minnesota, United States Changing Tides Therapeutic & Consultative Services, LLC Full time

    About Changing Tides Therapeutic & Consultative Services, LLCWe are a private mental health practice dedicated to providing trauma-sensitive therapeutic services to individuals, families, and couples in a compassionate and knowledgeable environment. Our team of licensed therapists values the importance of client collaboration and emphasizes the client as the...


  • Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job Summary:The Senior Quality Systems Engineer will drive Terumo Medical Corporation's efforts to ensure compliance with applicable global Quality System regulations in an efficient manner.Key Responsibilities:Support the management and effectiveness of the Quality Management System, primarily the Corrective Action and Preventive Action (CAPA) system...


  • Elkton, Maryland, United States Terumo Full time

    Job Summary:The Senior Quality Systems Engineer will play a critical role in ensuring compliance with global Quality System regulations, including 21 CFR Part 820 and ISO 13485:2016. This position will drive the management and effectiveness of the Quality Management System, primarily the CAPA system.Key Responsibilities:Provide guidance to CAPA Teams and...


  • Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job SummaryThe Senior Quality Systems Engineer will drive Terumo Medical Corporation's efforts to ensure compliance with applicable global Quality System regulations in an efficient manner.Key ResponsibilitiesSupport the management and effectiveness of the Quality Management System, primarily the CAPA system by:Providing guidance to CAPA TeamsParticipating...


  • Elkton, Maryland, United States Actalent Full time

    Job Title:Sr Complaints Quality EngineerJob Description:The Sr Complaints Quality Engineer will provide engineering support in post-market surveillance, with a focus on complaint investigations, product evaluations, root cause and complaint trend analysis.The associate is responsible for planning and coordinating the daily complaint engineering activities...


  • Elkton, Maryland, United States Northrop Grumman Full time

    Job Title: Senior Propulsion EngineerNorthrop Grumman is seeking a highly skilled Senior Propulsion Engineer to join our Motion Controls Engineering group at our Elkton, Maryland facility. As a key member of our team, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane, including building...


  • Elkton, Maryland, United States Northrop Grumman Full time

    Job Title: Senior Propulsion EngineerNorthrop Grumman is seeking a highly skilled Senior Propulsion Engineer to join our Motion Controls Engineering group at our Elkton, Maryland facility. As a key member of our team, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane, including building...


  • Elkton, Maryland, United States Northrop Grumman Full time

    Job Title: Senior Propulsion EngineerNorthrop Grumman is seeking a highly skilled Senior Propulsion Engineer to join our Motion Controls Engineering group at our Elkton, Maryland facility. As a key member of our team, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane, including building...


  • Elkton, Maryland, United States Northrop Grumman Full time

    Job Title: Senior Propulsion EngineerNorthrop Grumman is seeking a highly skilled Senior Propulsion Engineer to join our Motion Controls Engineering group at our Elkton, Maryland facility. As a key member of our team, you will be responsible for developing and executing a strategic plan to grow the Motion Controls market lane, including building...

  • Quality Engineer

    3 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...


  • Elkton, Maryland, United States Northrop Grumman Full time

    Job DescriptionJob Title: Senior Propulsion Engineering ManagerJob Summary:We are seeking a highly experienced Senior Propulsion Engineering Manager to lead our Motion Controls Engineering group at our Elkton, Maryland location. As a key member of our team, you will be responsible for developing and executing a strategic plan to grow the Motion Controls...


  • Elkton, Maryland, United States Northrop Grumman Full time

    Job DescriptionNorthrop Grumman is seeking a highly skilled and experienced Senior Propulsion Engineering Manager to lead our Motion Controls Engineering group at our Elkton, Maryland location.Key ResponsibilitiesDevelop and execute a strategic plan to grow the Motion Controls market lane, including building relationships with internal and external...


  • Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job Title: Manager, Value Stream Quality EngineeringJob Summary:The Manager, Value Stream Quality Engineering is responsible for overseeing all aspects of Operations Quality Engineering functions within the assigned value stream(s). This includes ensuring uniformity in cross-VS QE operating norms and execution, as well as coordinating with other VS QE...


  • 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...


  • 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...


  • 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...


  • 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 role will work closely with cross-functional teams to drive continuous improvement and ensure compliance to Terumo's quality policy.Key ResponsibilitiesCollaborate with IT, Operations,...


  • Elkton, United States Terumo Medical Corporation Full time

    Manager, VS Quality Engineering Date: Sep 26, 2024 Req ID: 3429 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: Quality Engineering Operations Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for...


  • Elkton, United States Terumo Medical Corporation Full time

    Manager, VS Quality Engineering Date: Jul 20, 2024 Req ID: 3429 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: Quality Engineering Operations Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for...


  • Elkton, Maryland, United States Terumo Medical Corporation Full time

    Job Summary:The Senior Director of Engineering will be responsible for leading and managing a team of engineers, overseeing engineering for manufacturing, sustaining, automation, process improvement, operational excellence, and molding and extrusion of high-quality medical devices within the healthcare industry.This leader is accountable for sustaining...


  • 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...