Quality Assurance Specialist
hace 1 día
**Revolutionize Dialysis Care with Outset Medical**
We're seeking a highly skilled Senior Supplier Quality Engineer to join our team at Outset Medical, a pioneering medical device company that's transforming the dialysis industry.
**Estimated Salary:** $120,000 - $160,000 per year
**Job Summary:**
The Senior Supplier Quality Engineer will play a critical role in maintaining and enhancing the quality of supplies procured by our business. This includes overseeing supplier performance, providing regular reports to management, and contributing to the refinement of supplier control plans.
**Responsibilities:
- Develop and implement strategies to elevate the quality of purchased products
- Conduct supplier audits and ensure compliance with audit schedules
- Analyze supplier trends and develop corrective actions to address quality issues
- Collaborate with suppliers to develop and implement process improvements
- Participate in Component Qualifications (PPAP), MSA, and supplier Control Plans
- Manage qualifications of changes and oversee associated change control activities
- Develop and prepare monthly suppliers quality trend analysis and reports
**Requirements:
- Bachelor's degree in engineering or technical field
- Minimum 7+ years of supplier quality or working with supplier qualification projects experience in a medical device or 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
- Ability to read and understand technical data (drawings, GD&T, etc)
**Why Join Outset Medical?**
We're a company that values innovation, collaboration, and customer satisfaction. Our team is passionate about creating a revolution in dialysis care, and we're committed to making a positive impact on patients' lives.
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