Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost & complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients & operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere & by anyone. The integration of water purification & on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission & a proprietary data analytics platform powering a new holistic approach to dialysis care.
The Senior Supplier Quality Engineer will ensure consistent delivery of high-quality supplies to the business. The SQE will monitor supplier performance & report results to management, aid in the continual improvement of supplier control plans, & develop & improve supplier quality for a variety of purchased products.
Essential Job Responsibilities
- Develop Supplier Improvement Plan
- Ensure Supplier Audit Schedule Compliance
- Supplier Trend Analysis to develop strategy
- Follow Up Corrective Actions, ensuring Root Cause tools are adequate for the issue reported
- Support or execute change orders for process improvements & determines when process stability & capability studies should be performed on existing suppliers.
- Analyzes and performs failure analysis to non-conforming products.
- Review & participates in the Component Qualifications (PPAP), MSA & supplier Control Plans
- Provides input to suppliers scorecards.
- Manage qualifications of changes & coordinates associated change control activities.
- Develops and prepares monthly suppliers quality trend analysis & reports.
- Team Member in Supplier Qualification & Maintenance process, including audits.
- Bachelor's degree in engineering or technical field.
- Minimum of 7+ years of supplier quality or working with supplier qualification projects experience in a medical device or other regulated industry is required.
- Strong verbal & written communication skills in English is required.
- Knowledge of medical device regulations & standards such as 21 CFR 820, GMP, EN ISO 13485, & ISO 14971.
- Able to read & understand technical data (drawings, GD&T, etc)
- Lead Auditor certification a plus.
- Lean Certification a plus.
- Competent using Microsoft Office suites.
- Experience with statistical analysis software a plus.
- Effective analytical, technical, & problem-solving skills. Applies rigorous methodology to complex problems, including six sigma methodology.
- Ability to multi-task & manage multiple assignments in a timely manner.
- Good communication & interpersonal skills.
- Strong analytical skills.
- Sound knowledge of sampling plan & other statistical techniques.