Software Quality Engineer II - Design Control & Validation

BD; Limerick; On-site; EUR 70,000 - 100,000; Full time

Job summary

BD is seeking a Quality Engineer to support software quality design assurance for medical devices. The role involves applying Quality engineering skills to new product development and maintenance, from inception to launch, while ensuring compliance with design controls, risk management, and change control processes.

You will collaborate with R&D and cross-functional teams, lead investigations, and drive continuous improvement initiatives to meet corporate and regulatory requirements.

Qualifications

• Bachelor's degree in Science, Technology, Engineering, or Mathematics or equivalent.
• Extensive knowledge of Medical Device standards and regulations incl. ISO 13485, ISO 14971, FDA QSR, IEC 62304, IEC 62366.
• Ability to implement systemic changes to improve product quality and efficiency.
• Experience with Design Verification, Design Validation, Test Method Validation, and Software Validation.

Responsibilities

• Participates on Project Teams as Quality Representative.
• Ensures Design Control principles are applied to product/process changes and new product development.
• Leads quality initiatives for products across the life cycle.
• Creates, reviews, and approves risk management files (RMM, Hazard Analysis, FMEA).
• Leads failure investigations and CAPA plans for continuous improvement.
• Creates, reviews, and approves design/verifications, validations, and related reports.
• Develops and improves Quality System documents (CAPA, Audits, Risk Management, Design Control).
• Drives quality planning for new product development and maintenance.
• Supports training on applicable standards and requirements.

Skills

Quality engineering

Regulatory knowledge

Risk management

FMEA

Design control

Communication

Education

Bachelor's degree in Science/Engineering

Tools

CAPA system

Risk management software

Job description

BD is seeking a Quality Engineer to support software quality design assurance for medical devices. The role involves applying Quality engineering skills to new product development and maintenance, from inception to launch, while ensuring compliance with design controls, risk management, and change control processes.

You will collaborate with R&D and cross-functional teams, lead investigations, and drive continuous improvement initiatives to meet corporate and regulatory requirements.