Director, Quality Engineering

The role

The Director of Quality Engineering leads the technical quality function supporting product development, manufacturing, suppliers, and sustaining engineering. This person manages the Quality Engineering team and partners with cross-functional departments to translate requirements and risks into controls.

What you will do

• Manage and develop the Quality Engineering team and inspection personnel.
• Define the Quality Engineering strategy across new product development, design transfer, and sustaining activities.
• Provide independent quality judgment in cross-functional decisions.
• Partner with R&D to establish measurable product requirements and demonstration methods.
• Lead Quality Engineering contributions to product risk management.
• Guide verification and validation strategies.
• Review technical protocols, results, deviations, and reports.
• Support design transfer for manufacturing and supplier capabilities.
• Lead Quality Engineering support for manufacturing and sustaining activities.
• Lead the technical quality interface with suppliers and contract manufacturers.

Required qualifications

• Bachelor’s degree in engineering or a closely related technical discipline.
• At least 10 years of progressively responsible, hands-on experience in medical-device quality engineering or closely related engineering roles.
• Experience supporting both new product development and sustaining or manufacturing activities.
• Demonstrated experience managing engineering personnel, setting technical direction, and developing team capabilities.
• Experience working with external suppliers or contract manufacturers on technical qualification, process controls, investigations, and improvements.
• Strong command of design controls, risk management, verification and validation, design transfer, process validation, and supplier quality engineering.
• Substantial applied statistical experience, including sampling, inference, process capability, measurement-system analysis, experimental design, and reliability methods.
• Proficiency with statistical software.
• Working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and the EU Medical Device Regulation.
• Experience with risk-based validation or assurance of quality-process software.
• Ability to influence cross-functional teams and explain complex technical issues to senior leadership.

Nice to have

• Experience with orthopedic implants, surgical instruments, and associated manufacturing processes, including applicable ASTM and ISO test standards.
• Experience with sterile products, packaging validation, cleaning validation, and sterilization.
• Experience with dimensional metrology, geometric dimensioning and tolerancing, and inspection of precision-manufactured components.
• Quality engineering experience with human tissue products.
• ASQ Certified Quality Engineer or comparable certification.
• Advanced degree in engineering, statistics, or a related technical discipline.

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.