Quality Assurance Manager

About the role

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. SI-BONE® is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System® provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date. We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are: Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly; Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo; Team Players: We roll-up our sleeves and work together as one team to achieve our goals.

Responsibilities

• Provide Quality Assurance and Quality Engineering support for SI-BONE products ensuring that the actions result in meeting our customer needs while maintaining compliance.
• In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QMSR, ISO 13485, MDSAP or ISO 14971), the employee has the authority to hold any product or Quality documentation from shipment or further processing.
• The employee has the responsibility and authority to report any instances to Regulatory and their respective management team.
• The employee must at all times act and conduct company business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the Adva