Quality Assurance Manager

The role

The Quality Assurance Manager manages the quality control group responsible for inspecting new and returned materials and final product release. This role provides quality assurance and engineering support for SI-BONE products to ensure compliance with standards and customer needs.

What you will do

• Manage and perform batch reviews and release product.
• Lead and mentor a team of QC Inspectors.
• Support Supplier Controls through audits, evaluations, and managing SCARs.
• Manage ASL for Sustaining products.
• Provide quality input for notified body follow up queries.
• Oversee and manage operational aspects of ongoing projects.
• Partner with external suppliers to assess design or process changes.
• Mentor peers and facilitate technical and professional development.
• Investigate product quality problems and implement corrective actions.
• Drive the CAPA/Non-Conformance process.

Required qualifications

• Bachelor’s degree in an engineering or technical science
• 6+ years of directly relevant experience
• minimum of 4 years of recent experience in FDA/cGMP or other regulated environment(s)
• 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.
• 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 ERP System (QAD)
• Experience with statistical quality tools
• Excellent verbal and written communication skills
• Must be a team player

Nice to have

• ASQ CQE certification
• Knowledge of the regulatory standards and practices for human tissue processing, storage and distribution
• Knowledge of Software Validation

About the company

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. The company focuses on improving the lives of patients with sacroiliac pelvic conditions.