Senior Quality Systems Engineer

4 weeks ago


Elkton, Minnesota, United States Terumo Full time

Job Summary:

The Senior Quality Systems Engineer will drive Terumo's efforts to ensure compliance with global Quality System regulations in an efficient manner.

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
  • Organize Stewardship reviews of CAPA documentation and manage the CAPA portfolio of projects
  • Establish and maintain CAPA process metrics
  • Lead activities related to the CAPA Board and work with Organizational Stakeholders to ensure CAPA and other quality system requirements are well understood

Requirements:

  • Demonstrated knowledge in 21 CFR Part 820, ISO 13485:2016, Medical Device Directive/Regulation
  • Strong computer knowledge, technical writing skills, and proofreading ability
  • Ability to develop, communicate, and support the interpretation and implementation of comprehensive quality systems/regulatory requirements
  • Advanced skill in developing and maintaining spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports
  • Ability to lead a group of participants from problem statement to root cause identification and verification of effectiveness
  • Ability to interact with all levels of management, coworkers, and regulators

Background:

  • 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 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

Terumo's Commitment to Diversity and Inclusion:

Terumo is an equal opportunity employer and values diversity of background and opinion. We 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 Terumo Full time

    Job Title: Senior Quality Systems EngineerJob Summary:The Senior Quality Systems Engineer will drive Terumo'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 CAPA systemProvide guidance to CAPA...


  • Elkton, Minnesota, United States Terumo Full time

    Job Summary:The Senior Quality Systems Engineer will play a key role in ensuring compliance with global quality system regulations, including 21 CFR Part 820 and ISO 13485:2016. This individual will drive the implementation of effective quality management systems, focusing on the CAPA process.Key Responsibilities:Provide guidance and support to CAPA...


  • Elkton, Minnesota, 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. This role will support the management and effectiveness of the Quality Management System, primarily the CAPA system, by providing guidance to CAPA Teams, participating...


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

    Job Summary:The Quality Systems Engineer II plays a critical role in driving Terumo Medical Corporation's Corporate CAPA Program to ensure compliance with global Quality System regulations, such as 21 CFR Part 820 and ISO 13485:2016. This position is responsible for establishing and maintaining CAPA process metrics, providing guidance to CAPA Teams, and...


  • Elkton, Minnesota, United States Terumo Full time

    Job SummaryThe Senior Engineer - Manufacturing Engineer position is responsible for ensuring the successful day-to-day operation and continuous improvement of a dedicated endovascular medical device manufacturing process within the Terumo Medical Corporation (TMC) Elkton, MD facility.In this role, the manufacturing engineer serves as the subject matter...


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

    Job SummaryThe Senior Process Engineer will provide 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 accordance within all TMC processes and...


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

    Job SummaryThe Senior Process Engineer position at Terumo Medical Corporation 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...


  • Elkton, Minnesota, United States Terumo Full time

    Job SummaryThe Quality Engineer II position plays a crucial role in ensuring that goods meet or exceed customer expectations and requirements. This role will work closely with the Operations and Engineering Team to drive continuous improvement and support production and project activities.Key ResponsibilitiesInvestigate and implement best-in-class Quality...


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

    Job SummaryThe Quality Engineer II position will work closely with the Operations and Engineering Team to ensure that goods are designed, developed, and made to meet or exceed our customer expectations and requirements. The position will support production and project activities and drive continuous improvement. Ensure compliance to Terumo's quality policy,...


  • Elkton, Minnesota, United States ITW Full time

    Job SummaryWe are seeking a highly motivated Field Service Engineer to join our team at Instron. As a Field Service Engineer, you will be responsible for traveling to customer sites to perform a variety of services including verification, preventative maintenance, repair, and installation of Instron's products.You will be provided with a company vehicle,...


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

    Job SummaryThis position is responsible for planning, directing, and implementing projects to improve manufacturing processes of existing products or development of new products that directly affect safety, quality, and productivity with the end result of producing a better quality product more efficiently.Responsible to provide direction of engineers,...


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

    Job SummaryThe Logistics and Distribution Automation Engineer II will play a pivotal role in sourcing, configuring, and ensuring the functionality of hardware systems within the L&D organization. This position will involve engaging with vendors and suppliers to ensure that the sourced hardware equipment meets the Terumo company's specifications and...


  • Elkton, Minnesota, United States Innova Solutions Full time

    Job Description: We are seeking a highly skilled Quality Assurance Specialist to support our manufacturing operations. The ideal candidate will have a strong understanding of cGMPs and Health Authority regulations, as well as experience in aseptic operations and quality assurance.Responsibilities:Support the review and approval of qualification activities,...


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

    Job SummaryThis entry-level position in the Facilities Engineering department involves performing maintenance on equipment and plant facilities to ensure functional accuracy and completeness, under the guidance and direction of Senior / Lead Facilities Engineers.ResponsibilitiesFollow requirements of TMC Quality System, including process controls,...


  • Elkton, Minnesota, United States Terumo Full time

    Job SummaryThis entry-level position in the Facilities Engineering department involves performing maintenance on equipment and plant facilities to ensure functional accuracy and completeness, under the guidance and direction of Senior / Lead Facilities Engineers.Key ResponsibilitiesFollow requirements of TMC Quality System, including process controls,...


  • Elkton, Minnesota, United States gpac Full time

    We are seeking a skilled Transportation Engineer to join our team at GPAC, a leading search firm specializing in placing quality professionals within multiple industries across the United States since 1990. Our client, a local multidisciplinary civil engineering firm, is looking to add a Transportation Engineer to their family-like team. They work on...


  • Elkton, Minnesota, United States Northrop Grumman Full time

    Job Summary:We are seeking an Electrical Controls Engineer to join our team at Northrop Grumman. The successful candidate will be responsible for designing and programming process automation and industrial controls, as well as coordinating efforts to modernize industrial control systems and hardware.Key Responsibilities:Work with process experts to create...


  • Elkton, Minnesota, United States Northrop Grumman Full time

    Job Title: Senior Financial Analyst for Strategic Programs Northrop Grumman is a global leader in defense and technology, and we are seeking a highly skilled Senior Financial Analyst to join our team. As a Senior Financial Analyst, you will play a critical role in supporting our strategic programs by providing financial analysis, budgeting, and...


  • Elkton, Minnesota, United States Food Lion Full time

    Job Summary:As a Quality Assurance Specialist at Food Lion, you will play a critical role in ensuring that our stores maintain the highest standards of quality and safety. You will be responsible for maintaining a clean and safe shopping environment, minimizing shrink through proper utilization of standard practices, and providing excellent customer...


  • Elkton, Minnesota, United States ChenMed Full time

    Job SummaryWe are seeking a highly skilled Primary Care Physician to join our team at ChenMed. As a physician-led organization, we are dedicated to transforming healthcare for seniors and improving health outcomes. Our mission is to provide exceptional patient care and deliver better health to our patients.Key ResponsibilitiesProvide high-quality patient...