22 days old

NPD Quality Engineer I

Elkton, MD
  • Job Code
JobId: 387018
JobTitle: NPD Quality Engineer I
Department: Product Quality Engineering
Location: Elkton
Description: Job Summary:
The NPD Quality Engineer I will assist the quality engineering (QE) activities associated with one or multiple New Product Development (NPD) projects to ensure compliance to internal and external requirements during the development and commercialization of new products.   With the guidance of the manager, this individual will provide QE guidance and partner with the NPD organization in efficient, effective and rapid development and commercialization of new products.  This individual will assist in the effective oversight of NPD QE activities, as well as participate as an active QE representative on project teams.  The NPD QE I manages the daily operation of the NPD quality aspects of one or multiple projects by ensuring timely completion of NPD Quality Assurance deliverables that meet the company standards for quality.   With the assistance of the manager, this individual will provide NPD teams with clear, consistent and timely feedback as it relates to compliance exposure and will provide innovative solutions to effectively resolve investigations and to meet the needs of customers, regulatory bodies and Terumo business requirements. 
As part of a project team and with the assistance of the manager, the NPD QE I will be responsible for developing sound Design History File deliverables, including, but not limited to, Quality Plans, Supplier Qualification Strategies\/Quality Agreements, Manufacturing Quality Plan, Design Verification protocols and reports, and conducting Design History File Verifications at the end of each design control phase.  In addition, the NPD QE I will actively participate in design characterization, risk management activities, and design and process validation.
Job Details:
  1. Assist Quality Engineering on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards.
  2. Provide focused quality engineering support and assume responsibility for timely and effective coordination and\/or execution of assigned project activities
  3. With the guidance of the manager, assist in quality system development and implementation throughout product life cycle
  4. Provide oversight for internal and external metrology, incoming inspection, acceptance criteria, disposition of non-conforming materials, and measurement system evaluations. 
  5. Assure that all applicable elements and product technical standards that are applicable to a design category are effectively incorporated into new designs and into changes to designs. 
  6. Review and approve\/reject technical transfer plans and reports from the design transfer perspective. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
  7. Assist in completion of Risk Management activities for new and\/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.
  8. Addresses defect prevention through review of quality history, supplier base controls, scrap analysis, process control techniques and training.
  9. Assist in developing and validating quality test methods.
  10. Is an active team member in supporting quality disciplines, decisions, and practices.
  11. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  12. Review product and process qualification and validation and other change control related documentation.
  13. Generate internal quality documentation such as standard operating procedures and inspection procedures.
  14. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer\/internal complaints.
  15. Performs analytical measurements and experiments to qualify or resolve product and process issues.
  16. Track quality trends and initiate action items to resolve issues.  Manage assigned corrective actions.

    Terumo is an Equal Opportunity Employer


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NPD Quality Engineer I

Elkton, MD

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Elkton, MD

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