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Supplier Quality Engineer

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Date: Jan 15, 2022

Location: Cartago, C, CR

Company: Terumo BCT, Inc.

Requisition ID:  28544  

 

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

 

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.

 

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. Consider joining our team and unlock your potential.

 

ESSENTIAL DUTIES

  • Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing equipment, facilities areas, and process utilities systems.
  • Manages projects including development of project scope and estimates, initiation of requests for capital when required, specification of equipment and installation requirements, management of costs to budget, and support of IQ/OQ and final documentation in accordance with acceptable engineering practices.
  • Conducts studies and makes recommendations for the purchase and implementation of new technologies, practices, tools, and equipment to maximize site effectiveness.
  • Prepares and reviews engineering/technical documents such as reports, SOP’s, protocols, schedules and budgets, and vendor provided documents and drawings.
  • Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations.
  • Provides work direction to engineering support staff. 
  • Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, indentifying problems, generating alternatives and recommending solutions. 
  • Follows department processes and regularly makes recommendations on these processes.
  • Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.
  • Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
  • Analyzes data and presents it in appropriate forums.
  • Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.
  • Works cross-functionally and proactively on supplier quality and management activities, including:
    • Management of injection molding projects including tracking of project scope, schedule, and budget.
    • Area of concentration includes Injection Molding, Thermoforming, and Extrusion for blood-contacting, disposable products
    • Component, process validations (IQ/OQ/PQ), verification and final documentation
    • Engineering Change Requests and Engineering Change Notices for supplier changes
    • Engineering/technical documents such as protocols, reports, specifications, drawings, and vendor provided documents
    • Statistical analysis including process capability, equivalency, and measurement system analysis (i.e. Gage R&R).
    • Supplier quality performance, including corrective and preventive actions
  • Implements and understands FDA or regulatory requirements as necessary
  • Follows technical specification requirements and provides feedback on various technical processes and procedures

 

OTHER DUTIES AND RESPONSIBILITIES

  • Work assignments may require additional development and a maturing or broadening of in-depth engineering skill(s).
  • May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

  • Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
  • Bachelor of Science Degree in Engineering, preferred.

 

Experience

  • Minimum 4 years experience.
  • Two years of GMP manufacturing experience required.

 

Skills

  • Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
  • Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, provides support for subordinates, junior engineers, technicians, and management.
  • Mechanical and electronic ability and aptitude to assist with equipment trouble-shooting.
  • Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.
  • Understanding of and adherence to GMP practices and FDA regulations.
  • Knowledge and ability to implement FDA or regulatory requirements as necessary.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • Knowledge and use of relevant PC software applications and skills to use them effectively. 

 

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
  • We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect – Appreciative of others
    • Integrity – Guided by our mission
    • Care – Empathetic to patients
    • Quality – Committed to excellence
    • Creativity – Striving for innovation


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