Extrusion Engineer - Global Supplier Quality

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.

• 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.

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.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

Lakewood, Colorado (hybrid) - Open to candidates willing to relocate to the area.

May require up to 10% travel based on business needs.

• General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.