1 yrs required
The Sr. Quality Assurance Engineer is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. The position manages quality assurance programs and processes to ensure the quality of product conforms to the established procedures and applicable regulatory requirements. The position utilizes technical expertise on the FDA’s QSR, ISO 13485, ISO 14971, MDD for Class I and Class II medical devices for capital equipment and their accessories.
The Sr. Quality Assurance Engineer position supports Mizuho OSI in achieving established goals and objectives and follows the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels set by Mizuho OSI.
EDUCATION AND EXPERIENCE: Bachelor’s degree in Science, or related field and 5 to 7 years of related experience in mechanical or electro machinal medical device manufacturing.
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Mizuho OSI is a U.S. based company founded over 40 years ago and the leader in the specialty surgical table and patient positioning markets. We are part of an international company, Mizuho Corporation based in Japan, who has more than 99 years of proven innovation in the medical device area, making us a truly global organization. We share a responsibility and commitment with our healthcare partners to provide cost-effective and innovative solutions that effectively meet the needs of all the surgeons who use our products. Mizuho OSI continues to collaborate with world class surgical and patient care thought leaders to ensure our products produce the most favorable patient outcomes possible. Our extensive innovative product portfolio and extraordinary services position the company to attract and maintain long relationships with our customers.