QA Specialist I - Medical Device CAPA & Audit

Socket.dev; Sibley (MS); On-site; USD 60,000 - 90,000; Full time

Job summary

Millstone Medical is seeking a QA Specialist to drive CAPA processes and support quality systems across multiple sites. You will investigate root causes, develop corrective actions, and support audits to ensure ISO/FDA compliance.

Ideal candidates have a Bachelor’s in Quality/Engineering with 3–5 years in medical device QA, strong documentation skills, and proficiency in Excel macros. On-site position offering comprehensive benefits.

Qualifications

• Bachelor’s Degree with 3-5 years of quality experience in medical device environment.
• Experience inspecting via scales/gauges/calipers and color charts.
• Knowledge of FDA/GMP and ISO requirements.
• Understanding of GD&T and ability to read and follow procedures in English.
• Ability to train others and work independently.

Responsibilities

• Facilitate Millstone’s CAPA system across sites; investigate root causes and implement corrective actions.
• Participate in internal and external audits.
• Perform special QA projects as needed within the department.

Skills

Root cause analysis

CAPA systems

Attention to detail

GMP compliance

GD&T

Team collaboration

Excel/macros

English procedures

Education

Bachelor’s Degree in Quality/Engineering

Tools

Microsoft Excel

PowerPoint

Word

Job description

Millstone Medical is seeking a QA Specialist to drive CAPA processes and support quality systems across multiple sites. You will investigate root causes, develop corrective actions, and support audits to ensure ISO/FDA compliance.

Ideal candidates have a Bachelor’s in Quality/Engineering with 3–5 years in medical device QA, strong documentation skills, and proficiency in Excel macros. On-site position offering comprehensive benefits.