Quality Engineer - Medical Devices, NPI & Validation

Pentangle Tech Services | P5 Group; Cincinnati (OH); On-site; USD 85,000 - 110,000; Full time

Job summary

Pentangle Tech Services | P5 Group in Cincinnati, OH seeks an experienced Quality Engineer to support QA, validation, and manufacturing activities for medical device products in a regulated environment.

The role emphasizes quality systems, process validation, risk management, and data-driven improvements, with close collaboration across Manufacturing, R&D, Validation, Regulatory, and Supplier Quality teams to ensure compliant, high-quality product launches.

Qualifications

• Bachelor's Degree in Mechanical Engineering or related field.
• Minimum 5 years of experience in Quality Engineering, Validation Engineering, or Manufacturing Engineering.
• Medical device industry experience is required.
• Experience in GMP, ISO 13485, and FDA-regulated environments.
• Strong knowledge of process validation, risk management, PFMEA, DFMEA, CAPA, and QMS.
• Experience with statistical analysis tools such as MSA, SPC, DOE, and Process Capability.
• Ability to interpret engineering drawings, GD&T, CMM reports, and quality documentation.
• Proficiency with Excel, Minitab, or similar statistical software.
• Excellent analytical, problem-solving, communication, and cross-functional collaboration skills.

Responsibilities

• Support quality and compliance in GMP, ISO 13485, and FDA environments.
• Analyze quality and manufacturing data to identify trends and support continuous improvement initiatives.
• Perform root cause analysis, troubleshooting, and CAPA activities.
• Support manufacturing operations by resolving quality issues and improving processes.
• Apply statistical quality tools including MSA, SPC, DOE, Process Capability Analysis, and Reliability Studies.
• Execute process validation activities including TMV, IQ, OQ, PQ, FAI, and Process Characterization.
• Review engineering drawings, GD&T, CMM reports, and dimensional inspection results.
• Perform dimensional and statistical analysis using Excel, Minitab, or similar tools.
• Support New Product Introduction (NPI), product validation, and commercial launch activities.
• Participate in PFMEA, DFMEA, Gage R&R, Risk Assessments, and Control Plan development.
• Support supplier quality activities including component qualification and process capability assessments.
• Collaborate with Manufacturing, R&D, Validation, Regulatory Affairs, and Supplier Quality teams.
• Ensure compliance with Quality Management System (QMS) requirements and drive continuous improvement initiatives.

Skills

Quality systems

Process validation

Risk management

Statistical analysis

Cross-functional collaboration

Problem-solving

Communication skills

Education

Bachelor's Degree in Mechanical Engineering or related field

Tools

Minitab

Excel

Job description

Pentangle Tech Services | P5 Group in Cincinnati, OH seeks an experienced Quality Engineer to support QA, validation, and manufacturing activities for medical device products in a regulated environment.

The role emphasizes quality systems, process validation, risk management, and data-driven improvements, with close collaboration across Manufacturing, R&D, Validation, Regulatory, and Supplier Quality teams to ensure compliant, high-quality product launches.