Quality Engineer – Med Device, Metrology & CAPA Lead

Millstone Medical; Olive Branch (MS); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental & Vision

Life, Disability

Paid Time Off

Tuition Reimbursement

Career Pathing

Job summary

Millstone Medical Outsourcing is seeking a highly skilled Quality Engineer to join our team in Olive Branch, MS. The role focuses on metrology, GD&T, CAPA, validation, and documentation to assure regulatory compliance and customer satisfaction.

You will develop procedures, train staff, support internal audits, and drive continuous improvement using Lean and Six Sigma methodologies in a fast-paced medical device environment.

Qualifications

• 3-5 years of experience in the medical device industry with focus on quality assurance.
• Strong knowledge of metrology, CAPA, GD&T, and validation processes.
• ASQ Quality Engineer certification or Six Sigma Green/Black Belt a plus.

Responsibilities

• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR through QA processes.
• Lead CAPA investigations and implement corrective actions.
• Develop and maintain quality system procedures, work instructions, and inspection criteria.
• Support training and continuous improvement initiatives (Lean, Six Sigma).
• Coordinate with customers during audits and quality assessments.
• Investigate customer complaints and perform root cause analysis.

Skills

Metrology

GD&T

CAPA

Validation

Training

Regulatory compliance

Documentation

Root cause analysis

Six Sigma

Customer liaison

Education

Bachelor's degree in Engineering

Tools

Metrology equipment

Job description

Millstone Medical Outsourcing is seeking a highly skilled Quality Engineer to join our team in Olive Branch, MS. The role focuses on metrology, GD&T, CAPA, validation, and documentation to assure regulatory compliance and customer satisfaction.

You will develop procedures, train staff, support internal audits, and drive continuous improvement using Lean and Six Sigma methodologies in a fast-paced medical device environment.