Quality Engineer, Medical Devices - Process Validation CAPA

Creative Solutions Services, LLC; Utah; On-site; USD 90,000 - 125,000; Full time

Job summary

Creative Solutions Services, LLC in Utah seeks an experienced Quality Engineer to lead manufacturing quality assessment, remediation, and continuous improvement for Class II/III medical devices in a regulated environment. The role emphasizes process validation, risk management, CAPA, supplier quality, and regulatory compliance, collaborating across Manufacturing, Engineering, R&D, and Regulatory Affairs.

The successful candidate will drive FPY improvements, review validation protocols, perform

Qualifications

• Bachelor's degree in Engineering or related technical discipline is required.
• Master's degree in Engineering or related field preferred.
• Hands-on experience with process validation (IQ/OQ/PQ), TMV, SPC, MSA, PFMEA, and CP analysis.

Responsibilities

• Lead manufacturing quality assessments, audit processes, and remediation activities.
• Drive FPY improvement, defect reduction, scrap reduction, and process improvements.
• Review and approve IQ/OQ/PQ protocols and validation reports.
• Evaluate TMV activities for measurement method validity and reliability.
• Conduct SPC, MSA, PFMEA, and process capability analyses to mitigate risks.
• Support CAPA, nonconformance, deviation, and corrective action activities.

Skills

Process validation

CAPA

Regulatory compliance

Risk management

Supplier quality

Statistical analysis (SPC/MSA/PFMEA)

Education

Bachelor's degree in Engineering

Master's degree preferred

Job description

Creative Solutions Services, LLC in Utah seeks an experienced Quality Engineer to lead manufacturing quality assessment, remediation, and continuous improvement for Class II/III medical devices in a regulated environment. The role emphasizes process validation, risk management, CAPA, supplier quality, and regulatory compliance, collaborating across Manufacturing, Engineering, R&D, and Regulatory Affairs.

The successful candidate will drive FPY improvements, review validation protocols, perform