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**About the Role**
Outset Medical is seeking a skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in all aspects of our medical device development and manufacturing processes.
**Key Responsibilities**
The successful candidate will have a strong background in quality assurance and engineering principles, with experience working in a fast-paced medical device environment. Your primary focus will be on developing and executing process validation strategies, managing non-conformances, and implementing CAPA's. You will also be responsible for tracking and reporting quality metrics, as well as providing data analysis and recommendations to management.
**Requirements**
To be considered for this role, you must have a bachelor's degree in engineering or a related field and at least 3-5 years of experience in quality assurance or a related field. You should have a solid understanding of medical device regulations and standards, including 21 CFR 820, GMP, EN ISO 13485, and ISO 14971. Additionally, you should be proficient in Microsoft Office suites and have excellent analytical, technical, and problem-solving skills.
