Senior Medical Device Quality Engineer

Katalyst Healthcares & Life Sciences; Richardson (TX); On-site; USD 90,000 - 150,000; Full time

Job summary

Katalyst Healthcares & Life Sciences seeks an experienced Senior Quality Engineer to support medical device programs in Richardson, TX. You will drive quality engineering activities across development, transfer, and sustaining stages, applying GD&T, metrology, and risk management per FDA, ISO 13485, and GMP standards.

Responsibilities include design controls, CAPA, DOEs, V&V planning, and supplier quality collaboration.

Qualifications

• 5+ years in medical device quality engineering.
• Knowledge of QMS, GMP, FDA quality requirements, and ISO 13485.
• Experience with design controls and risk management.
• CAPA, nonconformance, deviations, root cause analysis.
• DFMEA and PFMEA knowledge.
• V&V, IQ/OQ/PQ experience.
• GD&T and reading engineering drawings.
• Dimensional inspection/metrology experience.
• Experience with Windchill or PLM/eQMS.
• ISO 14971 knowledge and post-market surveillance.

Responsibilities

• Provide quality engineering support for medical device product development and manufacturing activities.
• Prepare, review, and maintain Quality Plans, protocols, reports, specifications, and engineering documentation.
• Review and approve verification and validation (V&V) protocols and reports.
• Develop and maintain risk management documentation, including DFMEA and PFMEA.
• Support process validation and equipment qualification activities, including IQ, OQ, and PQ.
• Manage nonconformances, deviations, CAPA, root cause investigations, and audit activities.
• Review Change Orders and assess product, process, quality, and regulatory impact.
• Apply statistical methods for process capability, sampling, and measurement system analysis.
• Support post‑market surveillance, complaint trending, and quality improvements.
• Prepare and maintain SOPs, Work Instructions, and QMS documentation.
• Support technical transfer and manufacturing transfer activities.
• Perform dimensional inspections of medical devices and components using contact and non‑contact metrology equipment.
• Read and interpret engineering drawings, blueprints, and GD&T specifications.
• Develop and execute inspection programs using OGP SmartScope systems.
• Collect and analyze dimensional data using optical comparators, digital microscopes, white light scanners, and hand gauges.
• Collaborate with engineering teams to determine appropriate measurement and inspection techniques.

Skills

Quality engineering

Regulatory knowledge

Documentation

Project management

Problem solving

Team collaboration

Tools

OGP SmartScope

Windchill

eQMS

Job description

Katalyst Healthcares & Life Sciences seeks an experienced Senior Quality Engineer to support medical device programs in Richardson, TX. You will drive quality engineering activities across development, transfer, and sustaining stages, applying GD&T, metrology, and risk management per FDA, ISO 13485, and GMP standards.

Responsibilities include design controls, CAPA, DOEs, V&V planning, and supplier quality collaboration.