Sr. Supplier Quality Engineer - TPR

Terumo•Caguas, PR

11d

About The Position

Terumo Medical Corporation is hiring a Sr. Supplier Quality Engineer to support and lead its Supplier Management process. The role works closely with Manufacturing, R&D, Supply Chain, and Quality Engineering to ensure suppliers and purchased components or services meet specifications and other requirements. The position provides day-to-day leadership to Quality Supply Chain teams and handles personnel performance and technical issues for employees under its charge. The role implements supplier-management activities including evaluation and qualification of suppliers, component and material qualifications, validations, ongoing supplier performance improvement, corrective action, supplier metrics, and nonconformance investigations. It also maintains supplier suitability records, supports audits, prepares monthly supplier performance reports, and stays current with applicable FDA, international, and industry requirements. The position ensures compliance with TPR procedures and applicable regulatory requirements.

Requirements

Bachelor’s or advanced degree in a related engineering field, or equivalent.
At least 2 years of supervisory experience.
At least 7 years of related experience in supplier approval or management.
Certification as a Quality Engineer or Quality Auditor by the American Society for Quality.
Training and certification in Six Sigma and Lean methodology.
Experience working with suppliers on medical product quality issues.
Experience evaluating suppliers, including on-site auditing.
Knowledge of medical product manufacturing and development.
Strong people skills and ability to energize and motivate staff.
Solid understanding of receiving inspection processes, including statistical sampling, component measurement techniques, specifications, and drawings.
Thorough working knowledge of quality-system methods and practices, including DOE, PFMEA, control plans, Lean Manufacturing, DMAIC, and root-cause analysis.
Ability to understand technology related to TMC products.
Good interpersonal and communication skills; strong technical business writing and oral communication skills.
Bilingual in English and Spanish.
Understanding of CAPA and closed-loop corrective action.
Proficiency with spreadsheet tools (including report formatting, graphing, and formula/calculation generation), databases, presentation tools, and project-management tools.

Responsibilities

Lead, organize, plan, direct, and control teams to achieve expected goals; motivate personnel and support strong performance.
Handle personnel scheduling, evaluations, discipline, coaching, staff selection and training, and communication of required HR information.
Review new supplier-add requests for quality-system impact and required controls.
Assess supplier suitability through questionnaires, quality agreements, and supplier-site evaluations.
Work with suppliers, R&D, Supply Chain, and Quality Engineering to qualify potential suppliers for development projects.
Facilitate and perform component and material qualifications, including supporting DFMEAs, PFMEAs, and control plans where required.
Facilitate validations and component acceptance activities, and identify when gage R&R studies are needed.
Build supplier relationships to ensure purchased components meet specifications and drive continuous improvement using methods such as Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis, and Lean Manufacturing.
Optimize process capability for significant characteristics through statistical analysis and supplier training and support in problem-solving and process improvement.
Apply root-cause analysis and recommend corrective actions.
Drive supplier actions to verify component and process quality at supplier sites and reduce the need for incoming inspection.
Manage the Supplier Corrective Action Request process and lead implementation of relevant supplier corrective actions.
Maintain and analyze supplier KPIs and Cost of Poor-Quality data, identify recurring trends, and drive actions to reduce internal and external failure costs.
Work with suppliers and Supply Chain to establish and manage continuous-improvement programs, including supplier ratings and scorecards.
Manage supplier-suitability databases and files and maintain accessible records for internal and third-party audits.
Generate a monthly Supplier Performance Report using discrepancy reports and supplier ratings.
Support investigation and root-cause determination for relevant supplier nonconformances.
Stay current with FDA and international requirements and industry trends regarding regulations and expectations.
Ensure compliance with TPR procedures and applicable regulatory agency requirements.
Perform other duties as assigned.