Quality Engineer – Medical Devices, Validation & CAPA

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

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.