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Manufacturing Quality Engineer II

Company: Terumo Medical Corporation
Location: Elkton
Posted on: June 24, 2022

Job Description:

Job Summary:This 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 customer complaints, perform audits, develop test methods, and/or write procedures for material characterization. - -Job Details:

  • -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 leader or team member in supporting quality disciplines, decisions, and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Review and approve product and process qualification and validation and other change control related documentation.
  • 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
  • Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. Ensure QA, FDA and ISO compliance in all areas of responsibilities.
  • Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
  • Must comply with requirements of applicable national and international regulations
  • Performs analytical measurements and experiments to qualify or resolve product and process issues.
  • Will be responsible for developing and implementing strategic quality plans, 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.
  • Track quality trends and initiate action items to resolve issues. -Manage assigned corrective actions. -
  • Monitor field quality and analyze field returns to determine root cause.
  • Provide training and support for quality system processes and quality engineering practices.
  • Perform other job related duties. -
    Position Requirements:
    • Knowledge, Skills & Abilities
    • 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
    • Prefer one year of auditor experience.
    • Communication skills both verbal and written.
    • Organizational skills as well as time management skills essential for project work.
    • Prefer certification as a CQA, CQE, or CQM, and member of the ASQ.
    • Excellent computer skills
    • Strong writing, mathematics and statistics skillsBackground Experience
      • Requires a minimum of a 4 year degree in engineering, life sciences, or similar.
      • Requires three to six years experience in a medical device quality assurance environment.

Keywords: Terumo Medical Corporation, Wilmington , Manufacturing Quality Engineer II, Engineering , Elkton, Delaware

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