Quality Engineer

Quality Engineer

Evolution Spine is looking for an experienced Medical Device Quality Engineer to join our team. In this role, you will be hands-on in the day-to-day quality operations that keep our medical device products safe, compliant, and market-ready — from inspecting incoming materials to supporting corrective actions and helping launch new products.

Responsibilities:

● Perform incoming, in-process, and final inspections against approved specifications and drawings.

● Review new product development documentation and support design reviews with R&D

● Support risk analysis activities per ISO 14971

● Conduct supplier process verification and validation activities.

● Qualify and monitor suppliers on the Approved Supplier List

● Investigate nonconformances, run root cause analysis, and drive corrective and preventive actions (CAPA)

● Support internal audits and help prepare for external and 3rd party audits.

● Track and trend customer complaints as input to CAPA.

● Write/Update/Review and maintain quality procedures, work instructions, and records.

● Calibrate and maintain inspection, measuring, and test equipment.

● Help maintain ISO 13485 certification and audit readiness (FDA, MDSAP)

Requirements

● 0-5 years of experience in a medical device quality assurance or quality engineering role; spine experience

● Bachelor's or master’s degree in Mechanical, Biomedical Engineering or related scientific fields.

● Working knowledge of quality tools such as root cause analysis, statistical techniques, and inspection methods

● Familiarity with ISO 13485, FDA QSR (21 CFR 820), and ISO 14971 preferred

● Strong written and verbal communication skills

● Highly organized, detail-oriented, and comfortable working in a deadline-driven environment

● Proficiency with Excel; experience with an electronic QMS (e.g., MasterControl) a plus

● Ability to prioritize tasks and manage multiple projects effectively.

Pay: $65,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• Dental insurance

Work Location: In person