Lead Design QA Engineer – Medical Devices

Quasar Medical | Medical Device Manufacturer; Galway; On-site; EUR 60,000 - 90,000; Full time

Job summary

Quasar Medical, a medical device manufacturer, is seeking a Design Quality Assurance Engineer to provide quality leadership across the product development lifecycle. You will ensure regulatory compliance, lead design controls, risk management, and continuous improvement to bring safe devices to market.

The role involves CAPA, change control, supplier engagement, audits, and collaboration with cross-functional teams, in an on-site cleanroom environment in County Galway, Ireland.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3 years of medical device design and development/quality assurance experience.
• Familiarity with FDA QSRs, medical device regulations and ISO 13485.

Responsibilities

• Lead Quality Engineer on projects, providing guidance to establish quality documentation and pilot production/scale-up plans.
• Ensure project teams use Quasar Medical Quality Systems and comply with regulations and standards.
• Conduct design risk assessments to verify function and safety.
• Own CAPA, change control, audits, product release, document control, DHF and device master records.
• Engage with customers and suppliers; audit and qualify new suppliers as needed; communicate proactively.
• Contribute to resolution of technical issues and drive continuous improvement.
• Ensure all work satisfies the Quality Management System requirements.
• Lead quality roles on client programs, and assist in designing/methodologies, materials, processes or products; document accordingly.
• Maintain comprehensive documentation across all R&D phases, including user needs, product requirements and risk/test planning.

Skills

Quality leadership

Regulatory compliance

CAPA management

Risk assessment

Documentation

Education

Bachelor's degree in Engineering

Tools

eQMS

FDA QSRs

ISO 13485

Job description

Quasar Medical, a medical device manufacturer, is seeking a Design Quality Assurance Engineer to provide quality leadership across the product development lifecycle. You will ensure regulatory compliance, lead design controls, risk management, and continuous improvement to bring safe devices to market.

The role involves CAPA, change control, supplier engagement, audits, and collaboration with cross-functional teams, in an on-site cleanroom environment in County Galway, Ireland.