Engineer 3 - Global Supplier Quality

Terumo BCT, Inc. • Denver, CO

2d • Hybrid

About The Position

As an Engineer 3 - Global Supplier Quality Engineer (SQE), you'll be responsible for working with suppliers to resolve quality issues, improve process reliability, repeatability, and controls.  The SQE must be proficient in tubing/vinyl extrusion, process controls, process validation and verification, technical report writing, CAPA investigations, process improvement and project management.

Requirements

• 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.

Responsibilities

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

Benefits

• multiple group medical, dental and vision plans
• a robust wellness program
• life insurance and disability coverages
• a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more
• a 401(k) plan with a matching contribution
• vacation and sick time programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees