Quality Assurance Manager

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.
  • Partner with multiple external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance. Help create qualification strategies to implement complex changes.
  • Mentor peers in the organization and help facilitate technical and professional development of others.
  • Investigate product quality problems, determine root cause, gather and analyze data and implement corrective action to reduce or eliminate cause.
  • Drive the CAPA/Non-Conformance process as either a CAPA/Non-Conformance owner or contributor where required for Sustaining products.
  • Create quality metrics which are communicated to the organization. This includes routine review of inspection data and preparation of statistical and operational performance reports.
  • Participate in investigations regarding customer complaints.
  • Manage software validation projects including creation of System Requirements, Risk Assessments, the creation and execution of test protocols.
  • Manage external and internal audits.
  • Support the SI-BONE Quality System.
  • Manage Preventive Maintenance and Calibration of Instruments/Equipment
  • Manage Dose Audit Testing of Terminally Sterile Products
  • Manage and implement the Radiation Safety and Protection Program for Radiation Machine such as the C-ARM. Act as the Radiation Safety Officer (RSO)
  • Other duties as assigned.

Knowledge, Education and Experience:

• Bachelor’s degree in an engineering or technical science
• 6+ years of directly relevant experience with a minimum of 4 years of recent experience in FDA/cGMP or other regulated environment(s)
• ASQ CQE certification preferred
• Knowledge of industry standards (FDA QMSR, ISO 13485, MDR, MDSAP)
• Experienced in Quality System requirements such as Design Control, Quality Control, Production Process Controls, Supplier Controls, Corrective and Preventive Action, and Non-Conformance.
• Knowledge of the regulatory standards and practices for human tissue processing, storage and distribution is a plus.
• Demonstrated ability to drive and deliver innovative, effective and timely solutions
• Ability to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving
• Expertise in the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up
• Knowledge of Software Validation a plus
• Knowledge of ERP System (QAD)
• Experience with statistical quality tools
• Excellent verbal and written communication skills
• Must be a team player

Salary range:  $141,000 - $155,000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.

Supplemental pay: bonus and stock