Carlsmed · 14 hours ago
Sr. Quality Engineer
Carlsbad, California, United States
Full-time
Onsite
Senior Level
$130K/yr - $145K/yr
7+ years expCarlsmed 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 role is responsible for owning quality deliverables for design transfer and leading supplier selection, qualification, and auditing within an ISO 13485 and MDSAP certified Quality Management System.
Health CareManufacturingMedical Device
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
Qualification
Required
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%
Benefits
100% of monthly healthcare, dental & vision insurance premiums
401(k) plan with employer matching
Unlimited PTO
Company
Carlsmed
Carlsmed manufactures and sells digital-to-device 3-D printed implant system for lumbar spine surgery.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$108.98MKey Investors
B CapitalU.S. Venture PartnersCove Fund
2025-07-23IPO
2024-03-18Series C· $64.5M
2022-04-19Series B· $30M
Leadership Team
Michael Cordonnier
Chairman, CEO and Co-Founder
Niall Casey
CIPO, CTO, Co-founder, Board Member
Recent News
2026-01-23
2026-01-13
2026-01-12
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