Senior Quality Engineer I — Lead Quality & Process Excellence

HIGHRIDGE Inc.; Olive Branch, Northern (MS, KY); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Job summary

Highridge Medical is seeking a Senior Quality Engineer I to drive quality systems across the product lifecycle for spinal solutions in Olive Branch, MS.

The role requires 5+ years in quality engineering, knowledge of QSR/ISO, CAPA, and statistics; experience with GMP practices and document control is preferred.

You will lead MRB/NCR, perform QA validations, collaborate with R&D and Operations, and develop KPI metrics, with salary range up to $100k and travel up to 10%.

Qualifications

• Minimum of 5 years of experience in quality engineering activities.
• Strong knowledge of blueprint/DG&T and inspection methods.
• Experience with CAPA, regulatory standards (FDA Part 820, ISO 13485).
• Statistical methods including SPC/DOE experience.
• Ability to work in cross-functional teams.

Responsibilities

• Lead MRB and NCR processes for quality issues.
• Perform Gage R&R and IQ/OQ/PQ validations.
• Generate KPI metrics and report to management.
• Lead CAPA investigations and continuous quality improvements.
• Collaborate with R&D and Operations across the product lifecycle.
• Review validation protocols and change requests.

Skills

Root Cause Analysis

GD&T

Statistical Analysis

Six Sigma

CAPA

Communication

Team Collaboration

Process Improvement

QA Documentation

IQ/OQ/PQ Validation

Education

B.S. in Engineering

CQE or Green Belt

Job description

Highridge Medical is seeking a Senior Quality Engineer I to drive quality systems across the product lifecycle for spinal solutions in Olive Branch, MS.

The role requires 5+ years in quality engineering, knowledge of QSR/ISO, CAPA, and statistics; experience with GMP practices and document control is preferred.

You will lead MRB/NCR, perform QA validations, collaborate with R&D and Operations, and develop KPI metrics, with salary range up to $100k and travel up to 10%.