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.

General 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. This position is required to be onsite 5 days a week.

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 AdvaMed Code, and all applicable laws and regulations, whether national, regional, state, or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code of Conduct, or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

Specific Responsibilities and Skills

The position of Quality Assurance Manager will manage the quality control group responsible for inspection of new and returned materials, and their final release. This role will help improve current processes and perform the activities listed below:

Manage and perform batch reviews and release product. This includes confirming SI-BONE products created by contract manufacturers meet all requirements for FDA and ISO compliance and SI-BONE quality standards prescribed by SI-BONE. This includes checking that QC testing of critical specifications, labeling of product that are compliant for both US and international products. Lead and mentor a team of QC Inspectors, overseeing review of product lot history records, inspection of RMA returns (implants, instruments, and instrument tray set) and coordination with logistics the priorities of parts to be released.
Support Supplier Controls by maintaining the process, performing supplier audits, performing supplier evaluations and managing Supplier Corrective Action Requests.
Manage/support ASL for Sustaining products, but may support new products as required
Provide quality input for notified body follow up queries.
Oversee and manage the operational aspects of ongoing projects. Monitor the project from initiation through delivery. Review status of projects and budgets; manage schedules and prepare status reports. Assess project issues and develop resolutions to meet productivity, quality, and client-satisfaction goals and objectives.