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Supplier Quality Engineer Level 4

JOB SUMMARY

Supplier Quality Engineering assignments include management of suppliers, projects, and component quality for sterilized, disposable products used in conjunction with Terumo BCT systems. Focus areas are extrusion processes and plastic injection molding.

Responsibilities include management of key suppliers' quality & performance, supplier process validation, process capability and controls, evaluation and implementation of supplier changes, writing technical reports, and other activities of limited scope.

ESSENTIAL DUTIES

• Expertise in the areas of tubing extrusion and plastic injection molding
• Conducts engineering studies and drives decisions for improvement to extrusion equipment, injection molds, measurement systems, and other process equipment to maximize quality of supplied components
• Guides the successful completion of large-scale Continuous Improvement programs and may function in a project leadership role.
• Applies technical expertise and problem-solving methodology to complex issues requiring in-depth evaluation of variable factors.  Leads root cause analysis, corrective and preventive actions.
• Communicates regularly and clearly with suppliers on topics of quality and manufacturing process capability. Develops an environment that facilitates continuous improvement.
• Analyzes data and applies statistical analysis including process capability, equivalence, and measurement system analysis (i.e. Gage R&R). Ability to presents it in appropriate forums.
• Works globally with the engineering and manufacturing teams of multiple factories, as well as other customer-facing stakeholders, to investigate and resolve problems.  Proactively identifies areas of opportunity and drives preventive action.
• Understands specifications, GD&T and appropriate inspection methods for different types of requirements
• Performs ISO 13485 and or ISO 9001-based audits of suppliers and conducts other assessments of supplier capability
• Mentors less experienced engineers and provides broad-based direction within functional area and cross functionally. 
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results, often influencing the outcome of the team(s)
• Thinks analytically regarding components and subassemblies functioning as a part of larger system

• Follows company and department processes and may develop new business processes that have significant impact

OTHER DUTIES AND RESPONSIBILITIES

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

Education

• Bachelor of Science degree or Master of Science degree
• Preferred education or equivalent experience in the field of mechanical engineering, materials, biomedical engineering, chemical engineering or cellular biology.

Experience

• Minimum 8 years of relevant experience.
• Four years of GMP manufacturing experience in the medical device industry or similar field.

Skills

• Solves problems of diverse scope and complexity
• Ability to apply technology principles to multiple tasks and to generate unique alternatives and solutions
• Continuous improvement mindset, e.g. LEAN, Six Sigma
• Knowledge in statistics and experience with Minitab preferred
• Effective presentation of information and engineering analysis
• Understanding of and adherence to GMP practices and FDA regulations.
• Interactive skills in cross-functional influence, mentoring and acceptance of guidance, partnering with others
• Can work under general direction, independently determining solutions, identifying risks, and avoiding serious delays and or expenditure of time and resources
• Clear communication and coordination with external organizations
• Understanding of and adherence to GMP practices and FDA regulations.
• Knowledge and use of relevant PC software applications and skills to use them effectively. 
• Demonstrated ability to communicate effectively both verbally and in writing.
• Project management

-Or-

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

PHYSICAL REQUIREMENTS

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.

Additional Physical Requirements

May require up to 15% travel based on business needs.