Senior Quality Assurance Engineer

hace 4 días


Tijuana, Baja California, México Outset Medical A tiempo completo

**Company Overview**

Outset Medical is a pioneering medical device company that is revolutionizing the field of dialysis. Our mission is to create a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost. We're giving providers time back to focus on patient care, and patients the power to take control of their life and get back to enjoying the things they love.

**Position Overview**:

The Senior Supplier Quality Engineer plays a critical role in maintaining and enhancing the quality of supplies procured by the business. They oversee supplier performance, providing regular reports to management to ensure transparency and accountability. Additionally, they contribute to the refinement of supplier control plans, aiming for continuous improvement in quality standards.

**Responsibilities**:

Develop and implement strategies to elevate the quality of purchased products across the board. Ensure supplier audit schedule compliance, analyze and perform failure analysis to non-conforming products, and review and participate in component qualifications (PPAP), MSA, and supplier control plans. Provide input to supplier's scorecards, manage qualifications of changes, and develop and prepare monthly suppliers quality trend analysis and reports.

**Required Qualifications**:

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. Strong verbal and written communication skills in English, knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971. Able to read and understand technical data (drawings, GD&T, etc.).

**Company Culture**

At Outset Medical, we believe every person matters. We're a team that expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. We believe in doing that by innovating everywhere with intelligent speed, and we're committed to creating a revolution in the field of dialysis.



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