Lead Design Quality Engineer, Medical Devices

HERO Recruitment Ltd.; Galway; On-site; EUR 60,000 - 75,000; Full time

Job summary

HERO Recruitment Ltd. seeks a Design Quality Assurance Engineer to support medical device development through design controls, risk management, and QA documentation across the product lifecycle.

The role ensures compliance with regulatory standards (FDA QSRs, ISO 13485) and the company’s QMS, leading CAPA, change control, supplier audits, and document control while collaborating with cross-functional teams to deliver safe and effective devices.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3 years of medical device design and development/quality assurance experience.
• Experience with FDA QSRs, medical device regulations and ISO 13485.
• Proven ability to lead product verification & validation activities.
• Experience using an electronic quality management system (eQMS) is a plus.

Responsibilities

• Lead Quality Engineer on projects, guiding teams to establish quality documentation.
• Ensure project teams follow Quasar Medical Quality Systems and regulatory standards.
• Conduct risk assessments of the design to ensure intended functionality.
• Manage CAPA, change control, audits, DHF, and device master records.
• Coordinate with customers and suppliers for effective information exchange and audits.
• Contribute to error-free design history files and design controls.
• Support continuous improvement projects and methodologies across programs.

Skills

Quality leadership

Regulatory compliance

Risk management

CAPA

Design controls

Auditing

eQMS

Education

Bachelor's degree in Engineering or related field

Job description

HERO Recruitment Ltd. seeks a Design Quality Assurance Engineer to support medical device development through design controls, risk management, and QA documentation across the product lifecycle.

The role ensures compliance with regulatory standards (FDA QSRs, ISO 13485) and the company’s QMS, leading CAPA, change control, supplier audits, and document control while collaborating with cross-functional teams to deliver safe and effective devices.