Senior Quality Engineer II: Lead QA for Spine Innovators

Highridge Medical LLC; Olive Branch (MS); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Job summary

Highridge Medical is seeking a Senior Quality Engineer I to lead quality engineering activities across the product lifecycle in spine solutions. You will drive QA compliance and collaboration with cross-functional teams to ensure patient safety and product quality.

Key tasks include MRB/NCR management, CAPA investigations, statistical analysis (SPC/DOE), and protocol development for IQ/OQ/PQ. Travel up to 10% is expected with a focus on continuous improvement.

Qualifications

• Minimum of 5 years of experience in quality engineering.
• Strong knowledge in GD&T and QA regulations (FDA/ISO 13485).
• Experience with CAPA, MRB/NCR processes.
• Statistical methods: SPC, DOE, and data-driven decision making.

Responsibilities

• Lead MRB and NCR processes for quality issues across the product lifecycle.
• Perform root cause analysis and CAPA investigations; drive improvements.
• Develop and qualify inspection methods; review IQ/OQ/PQ protocols and reports.
• Generate quality KPIs and report to management; collaborate with R&D and Operations.

Job description

Highridge Medical is seeking a Senior Quality Engineer I to lead quality engineering activities across the product lifecycle in spine solutions. You will drive QA compliance and collaboration with cross-functional teams to ensure patient safety and product quality.

Key tasks include MRB/NCR management, CAPA investigations, statistical analysis (SPC/DOE), and protocol development for IQ/OQ/PQ. Travel up to 10% is expected with a focus on continuous improvement.