Engineer 3 - Supplier Quality (Contract Manufacturing Organization)

Requisition ID:  34090  

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

As a Supplier Quality Engineer 3, you'll be responsible for working with Suppliers and Contract Manufacturing Organizations (CMO) to improving process reliability, repeatability, controls and resolution of quality issues.  Supplier Quality Engineers must be proficient at process controls, project management, process validation and verification, test method validations, process improvement, supplier auditing, supplier management, and CAPA investigations.  Position will have a focus on process development and validation, component / device quality, Quality plans, tool design and equipment requirements related to injection molding, blow molding, and high speed automation. 
 

ESSENTIAL DUTIES

• Supports relationship with key suppliers, including CMO(s) and acts as Point of Contact for resolution of quality and  technical issues.
• Functions as a member of the Supplier Engineering Team working cross-functionally and proactively on supplier quality and management activities.  These activities include:
  • Supplier performance monitoring
  • Tool Design and Process Development that drives zero defect approach to quality
  • New Product Introduction (NPI)
  • Area of concentration includes high speed automation, injection molding, & blow molding
  • Component, tooling, and process validations / verification
  • Test Method Valdiations
  • Project management of supplier quality initiatives.
  • Supplier selection, evaluations, and audits
  • Corrective and Preventative Action (CAPA)
• Perform independent evaluation, selection, and application in making adaptations and modifications to projects.
• Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
• Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Implements and understands FDA or regulatory requirements as necessary.
• Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.                 
• Advises team members pro-actively on technical ideas and promotes skill development of team work.
• Interacts with peers across projects to secure resources and commitments.
• Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
• Follows technical specification requirements and provides feedback on various technical processes and procedures.
• Presents effectively complex technical information/analysis, and responds to questions from technical staff members and management.  
• Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
• Work direction responsibility may include technicians and junior engineers.
• May work with manufacturing and other function