About Carlsmed

Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The Carlsmed aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time.

Position Description

As Senior Quality Engineer, you will work on projects related to proprietary implants, instrumentation, and design automation systems to enable personalized surgery. Occasional travel (up to 15% travel) for this role is required for supplier audits and supplier visits.

Responsibilities

• Function as Lead Auditor with responsibility of executing supplier qualifications and supplier surveillance audits. Responsible for audit plans, audit reports, and resolution of supplier audit non-conformances.
• Collaborate and build partnerships with key suppliers. Monitor and evaluate supplier metrics to identify trends.
• Review test protocol requirements, drawing specifications and tolerancing, test results, risk management matrices, quality plans, and documents associated with Design History Files.
• Function as Lead Quality Engineer to support Product Development design controls by ensuring hardware and software design meet compliance standards
• Determine verification and validation testing strategies of design changes to ensure product integrity and specifications requirements are met
• Update Standard Operation Procedures to aid in the development of a robust and compliant Quality Management System
• Support Non-conformance and CAPA program by leading investigations, root cause, and corrective action implementation plans

Qualifications

• Education: Bachelor’s degree in engineering
• Experience: 5 – 10 years of medical device quality experience required
• Experience with spine or orthopedics highly desired
• Experience in supplier quality highly desired
• Experience in software quality is a plus
• Able to effectively communicate with third party auditors

Skills

• Excellent verbal and written communication
• Ability to perform high quality work with speed
• Willingness to wear multiple hats when needed to enable excellent patient outcomes
• Self-directed, able to find answers

Equal Opportunity Employer

Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.

Compensation

We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The expected pay range is: $113,000 to $135,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.