Quality Assurance Specialist

3 hours ago


Elkton, Minnesota, United States Terumo Medical Corporation Full time
Job Summary

The 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, ensure compliance to Terumo's quality policy, and respond to customer complaints.

Key Responsibilities
  • Proactively investigate and implement best-in-class Quality Engineering practices.
  • Provide focused quality engineering support and coordinate the execution of assigned development project activities.
  • Establish effective corrective action plans and lead the implementation of quality assurance plans, process controls, and CAPA systems.
  • Act as a project lead or team member in supporting quality disciplines, decisions, and practices.
  • Apply sound problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Identify non-conformance trends and develop technical investigation plans.
  • Perform data analysis and execute experiments to qualify or resolve product and process issues.
  • Create, review, and approve internal documentation such as quality plans and standard operating procedures.
  • Develop product/process assurance plans and identify effective process control systems to support the development, qualification, and on-going manufacturing of products.
  • Responsible for developing and implementing master validation plans, validation protocols, inspection plans, and quality/regulatory compliance operating procedures to meet FDA and ISO requirements.
  • Provide training and support for quality system processes and quality engineering practices.
Requirements
  • Bachelor's degree in engineering, engineering technology, computer science, mathematics, or physics.
  • At least three years of experience in a medical device or highly regulated industry.
  • Experience working in a manufacturing environment preferred.
  • One year of auditor experience preferred.
  • Certification as a CQA, CQE, or CQM and member of the ASQ is preferred.
About Terumo Medical Corporation

Terumo Medical Corporation is a leading medical device manufacturer with a commitment to providing world-class products, training, and education programs that drive clear economic value, better clinical outcomes, and improved quality of life for patients. We believe in the power of personal growth and encourage our employees to progress in the direction they want to go by deepening their skills throughout their career.



  • 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...


  • Elkton, Minnesota, United States Saxon Global Full time

    Job SummaryThe Quality Assurance Manager is responsible for ensuring compliance with quality system regulations and company policies. This role involves managing quality operations functions within the manufacturing facility, establishing a work environment that supports compliance, and promoting a culture of quality excellence.Key ResponsibilitiesEstablish...


  • Elkton, Minnesota, United States Sentara Full time

    Job SummaryThe Nurse Practitioner (NP) or Physician Assistant (PA) is responsible for providing healthcare services to individuals, families, and/or groups under the direction of a primary care physician. The NP or PA conducts health assessments, prescribes treatments, promotes health, and provides disease prevention and management. The role requires...

  • Expert Professional

    2 weeks ago


    Elkton, Minnesota, United States Horizon Group Full time

    About Horizon GroupWe are a dynamic organization that values expertise and teamwork. Our employees are the driving force behind our success, and we strive to create an environment that fosters engagement, expertise, and creativity.The RoleWe are seeking a highly skilled Regulatory Compliance Expert to join our team. As a key member of our quality assurance...


  • Elkton, Minnesota, United States Christiana Care Full time

    Job SummaryWe are seeking a highly skilled Nuclear Medicine Technologist to join our team at Christiana Care. As a Nuclear Medicine Technologist, you will be responsible for performing diagnostic and therapeutic nuclear medicine procedures, as well as PET/CT procedures, in accordance with state regulations and under the guidance of physicians.Key...


  • Elkton, Minnesota, United States Banfield Full time

    About BanfieldWe're a leading general veterinary care practice in America, dedicated to providing high-quality preventive care and treatment to pets. Our mission is to create a better world for pets, and we're looking for a Credentialed Veterinary Technician to join our team.Role ResponsibilitiesProvide exceptional care to furry, feathered, and scaled pets,...

  • 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 CommuniCare Family of Companies Full time

    Director of Rehabilitation OpportunityCommuniCare Rehab, a member of the CommuniCare Family of Companies, has a Full Time opening for a Director of Rehabilitation at Laurelwood Healthcare Center, where our therapists and Leaders are In-House Team Members.About the RoleThis is an exciting opportunity to make a direct impact with our residents through therapy....


  • 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, 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...


  • Elkton, Maryland, United States Chili's Grill & Bar Full time

    Quality Assurance SpecialistAt Chili's Grill & Bar, we're committed to delivering exceptional dining experiences to our guests. As a Quality Assurance Specialist, you'll play a vital role in ensuring that every dish that leaves our kitchen meets our high standards of quality and taste.Key Responsibilities:Monitor food preparation to ensure consistency and...


  • Elkton, Maryland, United States Chili's Grill & Bar Full time

    Quality Assurance SpecialistAt Chili's Grill & Bar, we're committed to delivering exceptional dining experiences to our guests. As a Quality Assurance Specialist, you'll play a vital role in ensuring that every dish that leaves our kitchen meets our high standards of quality and taste.Key Responsibilities:Monitor food preparation to ensure consistency and...


  • Elkton, Maryland, United States Chili's Grill & Bar Full time

    Quality Assurance SpecialistAt Chili's Grill & Bar, we're committed to delivering exceptional guest experiences. As a Quality Assurance Specialist, you'll play a vital role in ensuring our food meets the highest standards of quality and taste.Key Responsibilities:Prepare food to company specifications, maintaining the highest standards of quality and...


  • Elkton, Virginia, United States Collabera Full time

    Job OverviewCollabera is seeking a highly skilled Quality Specialist to support our manufacturing operations. The ideal candidate will have a strong background in quality assurance and aseptic operations, with experience in the pharmaceutical industry.Key ResponsibilitiesSupport the review and approval of qualification activities, change controls, batch...


  • Elkton, Maryland, United States JBL Resources Full time

    Job SummaryWe are seeking a highly skilled Complaints Quality Assurance Specialist to join our team at JBL Resources. As a key member of our quality assurance team, you will be responsible for managing and resolving product complaints, ensuring that devices meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesInvestigation and...


  • Elkton, Maryland, United States Chili's Grill & Bar Full time

    About the RoleWe are seeking a highly motivated Quality Assurance Specialist to join our team at Chili's Grill & Bar in Elkton. As a Quality Assurance Specialist, you will play a critical role in ensuring that every guest receives perfectly prepared, high-quality food.Key ResponsibilitiesFood Preparation and Quality Control: Ensure that food is prepared to...


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

    Job SummaryAs a Manufacturing Quality Assurance Specialist at Terumo Medical Corporation, you will play a critical role in ensuring the quality of our medical devices. This position requires a high level of attention to detail and the ability to work independently with minimal supervision.Key ResponsibilitiesPerform in-process and finished product...


  • Elkton, Michigan, United States AUTOKINITON Full time

    Job DescriptionThis candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes at AUTOKINITON. They will utilize data analysis to better understand quality reporting measures and enhance processes.Key ResponsibilitiesProvide support and guidance for Process Sign Off Books and job...


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

    Job SummaryThis position is responsible for investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better quality product more efficiently. Ensure compliance to Terumo's quality policy, respond to...


  • Elkton, Maryland, United States Innova Solutions Full time

    Job Description:The ideal candidate will support manufacturing operations by becoming familiar with site processes, procedures, and policies, aligning with cGMPs and Health Authority regulations. This role will involve reviewing and approving qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other...


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

    Job Title: Quality Assurance ManagerTerumo Medical Corporation is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.Key Responsibilities:Develop and implement quality systems and procedures to ensure...


  • Elkton, Maryland, United States Saxon Global Full time

    Job Title: Sr. Manager, Quality AssuranceSaxon Global is seeking a highly skilled and experienced Sr. Manager, Quality Assurance to join our team. As a key member of our quality operations team, you will be responsible for ensuring compliance with regulatory requirements and driving quality excellence across our manufacturing facilities.Key...


  • Elkton, Maryland, United States Terumo Full time

    Job SummaryThe 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-value stream QE operating norms and execution, as well as compliance with applicable regulations in countries where Terumo Medical...


  • Elkton, United States Saxon Global Full time

    Summary The Manager, Quality Operations is responsible for managing quality operations functions within the respective manufacturing facility. Responsible for ensuring compliance with the applicable regulations of all countries in manufacturing and distributing products based on Quality System Regulation, and the Medical Device Directive. Responsibilities ...


  • Elkton, Maryland, United States CAD Engineering Resources Full time

    Job DescriptionWe are seeking a highly skilled Quality Engineer to join our team at CAD Engineering Resources.Job Summary:The Quality Engineer will be responsible for ensuring the quality of our products and processes, identifying and implementing process improvements, and collaborating with cross-functional teams to drive quality excellence.Key...


  • Elkton, Maryland, United States CAD Engineering Resources Full time

    Job SummaryWe are seeking a skilled Quality Inspector to join our team at CAD Engineering Resources.The successful candidate will be responsible for inspecting automotive parts according to written instructions, ensuring high-quality products are delivered to our customers.Key Responsibilities:Inspect parts using measurement gauges, calipers, and...


  • 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 Terumo Medical Corporation Full time

    Job SummaryAs a Manufacturing Inspector II, you will play a critical role in ensuring the quality of our products by performing in-process and finished product inspections. This position requires minimal supervision and involves working independently to identify and resolve quality issues.Key ResponsibilitiesPerform visual, functional, and dimensional...


  • Elkton, Maryland, United States Northrop Grumman Full time

    Job Title: Mission Assurance EngineerWe are seeking a highly skilled Mission Assurance Engineer to join our team at Northrop Grumman. As a Mission Assurance Engineer, you will be responsible for ensuring the quality and reliability of our products and services.Job Summary:The Mission Assurance Engineer will work closely with our engineering and quality teams...


  • Elkton, Maryland, United States Northrop Grumman Full time

    Job SummaryWe are seeking an experienced Mission Assurance Engineer to join our team at Northrop Grumman. As a Mission Assurance Engineer, you will be responsible for ensuring the quality and reliability of our products and services. You will work closely with our engineering and manufacturing teams to identify and mitigate risks, and ensure compliance with...