Quality Engineer - Medical Devices | CAPA, RCA & Validation

Medix™; Minneapolis (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading medical device company is looking for an Operations Quality Engineer to enhance manufacturing processes and manage quality issues. Key responsibilities include analyzing Nonconforming Material Reports, conducting root cause investigations, and developing process validation protocols. The ideal candidate has a deep knowledge of manufacturing operations and quality systems, particularly in the medical device sector. Strong communication skills and proficiency in Microsoft Office are essential for success in this role. Join us to drive continuous improvement and ensure operational excellence.

Qualifications

• Strong understanding of manufacturing operations and quality systems in a medical device context.
• Knowledge of ISO 13485 and FDA QSR requirements.
• Experience with Root Cause Analysis and risk management.
• Ability to interpret engineering drawings and specifications.

Responsibilities

• Manage and analyze Nonconforming Material Reports (NCMRs) and customer complaints.
• Conduct root cause investigations and implement corrective actions.
• Develop and execute process validation protocols.
• Lead investigations for manufacturing issues and ensure compliance.

Skills

Manufacturing operations knowledge

Quality systems understanding

Root cause analysis

Error-proofing methods knowledge

Proficiency in Microsoft Office

Strong communication skills

Tools

eQMS systems

Inspection tools

Job description

A leading medical device company is looking for an Operations Quality Engineer to enhance manufacturing processes and manage quality issues. Key responsibilities include analyzing Nonconforming Material Reports, conducting root cause investigations, and developing process validation protocols. The ideal candidate has a deep knowledge of manufacturing operations and quality systems, particularly in the medical device sector. Strong communication skills and proficiency in Microsoft Office are essential for success in this role. Join us to drive continuous improvement and ensure operational excellence.