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Terumo · 3 weeks ago

Engineer 3 - Global Supplier Quality

Lakewood, CO

Full-time

Hybrid

Mid Level

$106K/yr - $132K/yr

4+ years exp

Terumo Blood and Cell Technologies is a global leader in medical devices and related products, impacting patient lives worldwide. The Engineer 3 - Global Supplier Quality is responsible for ensuring supplier quality and process reliability, leading initiatives in quality management and compliance.

Health CareManufacturingMedicalMedical DeviceTraining

Responsibilities

Functions as a member of the Global Supplier Engineering Team working cross-functionally and proactively on supplier quality and management activities. These activities include:

Extrusion troubleshooting

Component, tooling, and process validations / verification with technical reports

Project management of supplier quality initiatives

Corrective and Preventative Action (CAPA)

Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources

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

Understands FDA or regulatory requirements as necessary

Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas

Advises team members pro-actively on technical ideas and promotes skill development of teamwork

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 functional groups on manufacturing and regulatory compliance issues

Performs ISO 13485 and or ISO 9001-based audits of suppliers and conducts other assessments of supplier capability

Qualification

Process validationGMP manufacturingProject managementTechnical report writingExtrusion troubleshootingCAPA investigationsFDA regulationsMechanical engineeringChemical engineeringFluids engineeringCellular biologyPC software proficiencyTechnical leadershipCommunication skillsTeam collaborationProblem-solving skills

Required

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

Minimum 4 years experience

Two years of GMP manufacturing experience required

Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology

Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management

Strong technical problem-solving skills

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