Sr. Quality Engineer

Carlsmed•Carlsbad, CA

About The Position

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.

Requirements

Bachelor’s degree in Engineering or related technical discipline.
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.
Experience supporting machined instruments, additive manufacturing, sterilization, and packaging suppliers.
Ability to travel up to 10%.

Responsibilities

Own quality engineering activities for NPI and design transfer, including planning, execution, and approval of quality deliverables.
Serve as Quality core team member for product development programs supporting implants, instruments, and additive manufacturing.
Ensure effective translation of design and risk outputs into manufacturing and supplier controls.
Support sustaining quality activities including MRB, NCR, and SCAR investigations.
Lead supplier selection, evaluation, qualification, and approval activities.
Plan and execute supplier audits; document findings and ensure timely closure of nonconformances.
Develop, implement, and maintain supplier scorecards and performance metrics.
Coordinate and approve supplier process, material, and site changes.
Support internal and external audits including ISO 13485 and MDSAP.
Act as a senior technical mentor within the Quality organization.
Process and equipment validation (IQ/OQ, PQ).
Analyze quality data and supplier performance metrics to drive continuous improvement and support data-driven supplier decisions.
Lead and review risk management activities, risk controls, and verification of risk mitigation effectiveness.