Quality Engineer - Medical Devices (GD&T, CAPA, Validation)

Millstone Medical; Olive Branch (MS); On-site; USD 70,000 - 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 Quality Engineer to ensure the highest quality standards in a fast-paced environment. The role focuses on metrology, GD&T, CAPA, validation, and continuous improvement initiatives.

You will also handle procedure writing, training, and customer liaison to ensure regulatory compliance and customer satisfaction. Responsibilities include leading CAPA investigations, performing metrology inspections, developing validation protocols, and supporting audits.

Qualifications

• 3-5 years of experience in the medical device industry, with a focus on quality assurance.
• Strong knowledge of metrology, CAPA, GD&T, and interpretation of engineering drawings.
• Experience with validation processes (IQ, OQ, PQ) and regulatory standards.

Responsibilities

• Lead investigation of quality issues, root cause analysis, and corrective actions.
• Perform dimensional inspections and ensure measurement system accuracy and traceability.
• Develop and maintain validation protocols and reports to meet regulatory requirements.
• Write procedures, train staff, and support customer liaison and audits.
• Support internal auditing program and data analysis for CAPA investigations.
• Drive continuous improvement projects (Lean, Six Sigma) to reduce defects.

Skills

Metrology

CAPA

GD&T

Validation

Training

Continuous Improvement

Customer Liaison

Regulatory Compliance

Procedure Writing

Documentation

Education

Bachelor's degree in Engineering

Tools

Metrology equipment

QMS software

Job description

Millstone Medical Outsourcing is seeking a Quality Engineer to ensure the highest quality standards in a fast-paced environment. The role focuses on metrology, GD&T, CAPA, validation, and continuous improvement initiatives.

You will also handle procedure writing, training, and customer liaison to ensure regulatory compliance and customer satisfaction. Responsibilities include leading CAPA investigations, performing metrology inspections, developing validation protocols, and supporting audits.