Sr. Quality Engineer
Carlsmed is seeking an experienced Senior Quality Engineer to support New Product Introduction (NPI), design transfer, product sustaining, and supplier quality activities for spine implants and instrumentation. This senior individual contributor role owns quality deliverables for design transfer and leads supplier selection, qualification, auditing, performance monitoring, and change management activities within an ISO 13485 and MDSAP certified Quality Management System.
The Senior Quality Engineer will own quality engineering activities for NPI and design transfer, including planning, execution, and approval of quality deliverables. Responsibilities include serving as the Quality core team member for product development programs supporting implants, instruments, and additive manufacturing, ensuring effective translation of design and risk outputs into manufacturing and supplier controls, supporting sustaining quality activities including MRB, NCR, and SCAR investigations, leading supplier selection, evaluation, qualification, and approval activities, planning and executing supplier audits, developing and maintaining supplier scorecards and performance metrics, coordinating and approving supplier process, material, and site changes, supporting internal and external audits including ISO 13485 and MDSAP, acting as a senior technical mentor within the Quality organization, conducting process and equipment validation (IQ/OQ, PQ), analyzing quality data and supplier performance metrics to drive continuous improvement, and leading and reviewing risk management activities, risk controls, and verification of risk mitigation effectiveness.
Candidates must possess a Bachelor's degree in Engineering or a related technical discipline and have over 7 years of progressive medical device quality engineering experience. Experience owning design transfer activities, strong knowledge of ISO 13485 and MDSAP requirements, experience with supplier auditing and supplier quality management, and experience supporting machined instruments, additive manufacturing, sterilization, and packaging suppliers are required. The ability to travel up to 10% is also necessary.
Carlsmed offers a competitive salary and benefits package, including paying 100% of monthly healthcare, dental, and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected pay range is $130,000 to $145,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.
Carlsmed is a commercial-stage medical technology leader and creator of the personalized spine surgery market with pioneering technology that is transforming spine surgery. The company has developed the cutting-edge aprevo® Technology Platform that personalizes surgical procedures through a combination of proprietary AI-driven software and patient-specific fusion devices.