Global Supplier Quality Engineer II

JOB SUMMARY

Terumo BCT is currently seeking qualified candidates for the position of Supplier Quality Engineer II, which is responsible for working with Suppliers to improve process reliability, repeatability, controls and resolution of quality issues.  Supplier Quality Engineers must be proficient at process controls, project management, process validation and verification, test method validations, process improvement, supplier auditing, supplier management, and CAPA investigations.  Seeking candidates with strong quality improvement, supplier development, and process improvement skills. 

Work requires originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.  Performs work which requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties.  Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

ESSENTIAL DUTIES

• Supports the overall Supplier Quality Team in resolving critical quality issues and complaint responses
• Functions as a member of the Supplier Engineering Team working cross-functionally and proactively on supplier quality and management activities.  These activities include:
• Supplier Development and Process Improvement
• Supplier Auditing and Performance monitoring
• Component, tooling, and process validations / verification, including Installation, Operational, and Performance Qualification (IQ/OQ/PQ) and revalidation activities
• Test Method Validations and Gage Correlation.
• Project management of supplier quality initiatives.
• Supplier selection, evaluations, and qualification.
• Supplier Corrective Action Requests (SCARs) management

• Manages supplier quality performance, including corrective and preventive actions and performance metrics; leads SCAR and CAPA investigations using structured root-cause methodologies (e.g., 5-Why, Fishbone, DMAIC) and verifies effectiveness of corrective and preventive actions
• Works on-site at supplier(s) to address quality or delivery concerns and develops an environment that facilitates continuous improvement
• Approves disposition nonconforming product and facilitates implementation of product/process changes.
• Defines and oversees containment and interim controls during supplier non-conformances, and drives long-term corrective action through to effectiveness verification.
• Participates in CTQ identification, PFMEA, and control-plan development and maintenance for supplier-manufactured components, and verifies that supplier monitoring systems align with the agreed control strategy.
• Reviews and approves Supplier Change Notifications (SCN) and supporting documentation; participates in internal change-control processes for impacted components.
• Conducts proactive supplier risk assessments (technical, supply continuity, and compliance) and drives mitigation actions in partnership with cross-functional teams.
• Ensures supplier processes for assigned commodities comply with FDA 21 CFR 820, ISO 13485, and applicable global regulatory standards.
• Supports audit readiness activities and represents Supplier Quality during internal and external audits as required.
• Performs ISO 13485 and or ISO 9001-based audits of suppliers and conducts other assessments of supplier capability
• Analyzes data and applies statistical analysis including Design of Experiments (DOE), process capability (Cp/Cpk/Ppk) and worst-case window development, equivalence, and measurement system analysis (i.e. Gage R&R). Presents it in appropriate forums.
• Works well in cross-functional teams to prepare and review engineering/technical documents such as protocols, reports, specifications, drawings, and supplier provided documents
• Evaluates and qualifies suppliers of components, OEM products, and contract manufacturing services
• Collaborates with manufacturing, addressing quality & delivery issues that impact production

• Follows company and department processes and makes recommendations on these processes

• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results
• Knowledge of plastic injection molding, extrusion, thermoforming and other relevant manufacturing processes

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.

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 of relevant experience.
• Two years of GMP manufacturing experience in a regulated industry or similar field.

Skills

• Project management and coordination with cross-functional team members
• Understanding of GD&T, Gage R&R, and Correlation studies
• Qualified Lead Auditor (ISO13485)
• Understanding of and adherence to GMP practices and FDA regulations.
• Continuous improvement mindset, e.g. LEAN, Six Sigma
• Provides support for technicians, quality specialists, and management.
• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues
• 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 databases, and skills to use them effectively. 
• Solves moderately complex problems, identifying problems, generating alternatives and recommending solutions. 

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

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