Software Quality Engineer II Medical Device QA Innovator

Becton Dickinson; Limerick; On-site; EUR 45,000 - 68,000; Full time

Job summary

Becton Dickinson is seeking a Quality Engineer to support Software Quality Design Assurance for UCC products in Limerick, Ireland. You will drive quality across the product lifecycle, from development to maintenance, ensuring design control, risk management, and regulatory compliance.

The role requires strong communication, teamwork, and leadership in cross-functional teams. You will contribute to continuous improvement and ensure product quality aligns with corporate policy and medical device

Qualifications

• Bachelor's Degree in Science, Technology, Engineering, or Mathematics, or relevant equivalent qualification
• Extensive knowledge of Medical Device standards and regulations including ISO 13485, ISO 14971, FDA regulations QSR, IEC 62304 Medical device software life cycle and IEC 62366 Usability
• Ability to understand Medical Devices Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency
• Expertise in Design Verification, Design Validation Process, Test Method, and Software Validation for Medical Devices
• Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership technique, time management, project management methodologies and able to balance multiple task assignments
• Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience

Responsibilities

• This role will be supporting Software Quality Design Assurance for UCC products. The QE is involved in new product development and product maintenance through the application of Quality engineering skills.
• Must be able to handle multiple projects and tasks, from product inception through product launch and maintenance utilizing a high level of written and oral communication skills.
• Represents the Quality Function on Project Teams for both new product development and existing products.

Skills

Quality engineering

Leadership on teams

Design verification

Software validation

Risk management

Regulatory knowledge

Education

Bachelor's Degree in Science, Technology, Engineering, or Mathematics, or relevant equivalent qualification

Job description

Becton Dickinson is seeking a Quality Engineer to support Software Quality Design Assurance for UCC products in Limerick, Ireland. You will drive quality across the product lifecycle, from development to maintenance, ensuring design control, risk management, and regulatory compliance.

The role requires strong communication, teamwork, and leadership in cross-functional teams. You will contribute to continuous improvement and ensure product quality aligns with corporate policy and medical device