Design Quality Engineer - NM47679

Description

Our client is seeking a Design Quality Engineer who will develop and implement compliance strategies to support New Product Introductions (NPI) and current marketed products within the areas of design, design transfer, manufacturing and service. As a critical member of the NPI core team you will ensure adherence to the Quality Management System (QMS) and regulatory requirements.

• Lead root cause analysis and corrective and preventive actions (CAPA) for design-related issues.
• Prepare and present design quality reports to management, highlighting trends, risks, and opportunities for improvement.
• Conduct design reviews and risk assessments, including Failure Mode and Effects Analysis (FMEA), to identify and mitigate potential risks.
• Creating the required documentation to support effective global regulatory submissions, liaising with external bodies to ensure their speedy acceptance.
• Participate in the development and implementation of quality metrics and key performance indicators (KPIs) to monitor and improve design quality.
• Manage design verification and validation activities, ensuring compliance with regulatory requirements and industry standards.
• Stay current with industry standards, regulatory updates, and best practices to continuously improve design quality processes.
• Develop and validate test methods, inspection procedures, and quality control processes for new products.
• Provide training and support to R&D and manufacturing teams on quality principles, procedures, and regulatory requirements.
• Collaborate with R&D teams to ensure quality considerations are integrated into all stages of the product development lifecycle.
• Develop, implement, and maintain design quality assurance processes in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards.
• Global impact: Contribute to advancing healthcare diagnostics worldwide
• Support the creation and maintenance of Design History Files (DHF) and Device Master Records (DMR) in accordance with regulatory requirements.

Requirements

If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search.

• 3+ years of experience in a design quality engineering role, preferably within the medical device industry.
• Proficiency in statistical analysis tools and software (e.g., Minitab.).
• Strong organisational skills and attention to detail.
• Ability to work independently and collaboratively in a team environment.
• Bachelor’s degree in Quality Assurance, Engineering, Life Sciences, or a related field.
• Certification in quality engineering (e.g., ASQ Certified Quality Engineer) is a plus.
• In-depth knowledge of QMS standards and regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820.
• Strong analytical and problem-solving skills with experience in root cause analysis and CAPA.

Benefits

• Fully onsite
• Career growth: Opportunities for professional development and progression
• Innovative environment: Work with cutting-edge diagnostic technologies
• Competitive salary and benefit package
• Located in North Wicklow, with parking

Training + Development

Interview process

Visa Sponsorship

Security clearance