Quality Engineer

Pentangle Tech Services | P5 Group; Kentucky; On-site; USD 85,000 - 115,000; Full time

Job summary

Pentangle Tech Services | P5 Group is seeking an experienced Quality Engineer to support quality assurance, validation, and manufacturing activities for medical device products in a regulated environment.

The ideal candidate will have experience with quality systems, process validation, risk management, statistical analysis, and new product introduction while working closely with cross-functional engineering and manufacturing teams.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• Minimum 5 years in Quality/Validation/Manufacturing Engineering in medical devices.
• Experience with GMP, ISO 13485, and FDA-regulated environments.
• Strong knowledge of risk management, PFMEA/DFMEA, CAPA, and QMS.

Responsibilities

• Support GMP/ISO 13485 and FDA-regulated manufacturing activities.
• Analyze quality and manufacturing data to identify trends and drive improvements.
• Perform root cause analysis and CAPA activities.
• Support manufacturing operations by resolving quality issues.
• Apply statistical tools including MSA, SPC, DOE, and Process Capability analysis.
• Execute process validation activities (IQ, OQ, PQ, TMV, FAI, Process Characterization).
• Review drawings, GD&T, CMM reports, and dimensional results.
• Perform dimensional and statistical analysis using Excel and Minitab.
• Support New Product Introduction (NPI) and product validation.
• Participate in PFMEA, DFMEA, Gage R&R, risk assessments, and control plan development.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supplier Quality.
• Ensure compliance with QMS requirements and drive continuous improvement.

Skills

Quality systems

CAPA

Root cause analysis

Cross-functional collaboration

Problem-solving

Education

Bachelor's Degree in Mechanical Engineering

Tools

Minitab

Excel

Job description

We are seeking an experienced Quality Engineer to support quality assurance, validation, and manufacturing activities for medical device products in a regulated environment. The ideal candidate will have experience with quality systems, process validation, risk management, statistical analysis, and new product introduction while working closely with cross-functional engineering and manufacturing teams.

Key Responsibilities

• Support quality and compliance activities within GMP, ISO 13485, and FDA-regulated manufacturing environments.
• Analyze quality and manufacturing data to identify trends and support continuous improvement initiatives.
• Perform root cause analysis, troubleshooting, and corrective/preventive action (CAPA) activities.
• Support manufacturing operations by resolving quality issues and improving production 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.

Required Qualifications

• Bachelor's Degree in Mechanical Engineering or a related engineering discipline.
• Minimum 5 years of experience in Quality Engineering, Validation Engineering, or Manufacturing Engineering.
• Medical device industry experience is required.
• Experience working within GMP, ISO 13485, and FDA-regulated environments.
• Strong knowledge of process validation, risk management, PFMEA, DFMEA, CAPA, and Quality Management Systems.
• 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.

Preferred Qualifications

• Experience supporting surgical products, implantable devices, or other complex medical devices.
• Experience with New Product Introduction (NPI) and product commercialization.
• Six Sigma Green Belt or Black Belt certification.
• Experience with supplier quality, component qualification, and supplier validation activities.