Quality Assurance Specialist

1 day ago


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

The 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, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization.

Key Responsibilities
  • Proactively investigates, identifies, and implements 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 action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Acts as an effective project lead or team member in supporting quality disciplines, decisions, and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Identify non-conformance trends and develop technical investigation plans. Investigates and analyzes customer/internal complaints.
  • Performs data analysis and executes experiments to qualify or resolve product and process issues.
  • Creates, reviews, and approves internal documentation such as quality plans and standard operating procedures.
  • Develop product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Responsible for developing and implementing master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.
  • Provide training and support for quality system processes and quality engineering practices.
  • Perform other job-related duties.
Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

  • 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
  • Communication proficiency; verbal and written.
  • Problem Solving and Critical Thinking
  • Detail Oriented
  • Initiative
  • Decision Making
  • Results Oriented; self-motivated and self-driven
  • Excellent organizational and time management skills.
  • Excellent computer skills
  • Good writing, mathematics, and statistics skills.
Qualifications/Background Experiences

Bachelors degree (4 years) or higher from an accredited course of study, in engineering, engineering technology, computer science, mathematics, or physics

Requires at least three (3) years 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

Terumo Medical Corporation is an equal opportunity employer and welcomes applications from diverse candidates.



  • 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 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 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 Food Lion Full time

    {"title": "Quality Assurance Associate", "description": "Job SummaryFood Lion is seeking a Quality Assurance Associate to maintain high standards of quality and safety in our stores. As a key member of our retail operations team, you will be responsible for ensuring a clean, safe, and inviting shopping environment for our customers.Key...


  • Elkton, Minnesota, United States Terumo Medical Corporation 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, ensure compliance to Terumo's quality policy, and respond to customer complaints.Key ResponsibilitiesProactively...


  • 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 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 Food Lion Full time

    Job SummaryWe are seeking a Quality Assurance Associate to join our team at Food Lion. As a Quality Assurance Associate, you will be responsible for maintaining high standards of cleanliness and sanitation in our stores, ensuring a safe and inviting shopping experience for our customers.Key Responsibilities:Maintain a clean and safe store environment,...


  • Elkton, Minnesota, United States Manpower Group Inc. Full time

    Job Title: Quality Engineer IIWe are seeking a highly skilled Quality Engineer II to join our team at Manpower Group Inc. in Elkton, MD. As a Quality Engineer II, you will play a critical role in ensuring that our medical devices meet or exceed customer expectations and requirements.Key Responsibilities:Investigate and implement best-in-class Quality...


  • 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 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.Key Responsibilities:Develop and implement quality assurance plans and procedures to ensure...

  • Culinary Specialist

    2 days ago


    Elkton, Minnesota, United States Golden Corral Full time

    Job Summary:The Culinary Specialist is responsible for the quality, quantity, and freshness of all Hot Choice Buffet products. This role requires attention to speed, cleanliness, organization, and product specifications. Key responsibilities include food production, operational excellence, and cleanliness.Key Responsibilities: Prepares Hot Choice Buffet...


  • Elkton, Minnesota, United States Terumo Medical Full time

    Job Title: Medical Device Production SpecialistWe are seeking a highly motivated and detail-oriented Medical Device Production Specialist to join our team at Terumo Medical in Elkton, MD.Job Summary:The Medical Device Production Specialist will be responsible for performing manual and repetitive job duties in support of the production department.Key...


  • Elkton, Minnesota, United States ChristianaCare Full time

    Job Title: Nuclear Medicine TechnologistChristianaCare is seeking a skilled Nuclear Medicine Technologist to join our team. As a key member of our healthcare team, you will be responsible for performing diagnostic and therapeutic nuclear medicine procedures, as well as assisting physicians in the diagnosis and treatment of diseases.Key...


  • Elkton, Minnesota, United States Christiana Care Full time

    Job Summary:We are seeking a skilled Perioperative Billing Specialist to join our team at ChristianaCare. As a key member of our revenue cycle team, you will be responsible for ensuring accurate and timely submission of computerized and paper billing for our Perioperative services.Key Responsibilities:Document implants used for surgical cases and coordinate...

  • Medical Assistant

    5 days ago


    Elkton, Minnesota, United States ChristianaCare Full time

    Urology Medical Assistant OpportunityChristianaCare Urology is seeking a skilled Medical Assistant to join our team.As a Medical Assistant in our Urology department, you will play a vital role in providing exceptional patient care and support to our urology specialists.Key Responsibilities:Prepare patients for virtual and on-site visits, including point of...


  • 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...


  • Elkton, Minnesota, United States AMN Healthcare Allied Full time

    Job Title: Physical Therapist - Skilled Care SpecialistAbout the Job:We are seeking an experienced Physical Therapist to join our team at a skilled nursing facility in Elkton, MD. As a Physical Therapist, you will be responsible for providing high-quality patient care and developing individualized treatment plans to help patients achieve their...

  • Expert Professional

    1 month 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 Sentara Full time

    Job SummaryThe Nurse Practitioner (NP) or Physician Assistant (PA) plays a vital role in providing high-quality healthcare services to individuals, families, and groups in a collaborative environment. This position requires a strong foundation in conducting health assessments, prescribing treatments, promoting health, and managing disease.Key...