Job Title:
Design Quality Engineer
Location:
Bray/Ireland/Hybrid
Department:
Quality
Reports To:
VP of Quality but day to activities will be the Project Manager for CGM/Biosensors
Position Type:
Full-Time
Job Summary:
The Design Quality Engineer 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. By employing strong critical thinking and influencing skills you will work cross-functionally to ensure robust Quality decisions. In this role, you will have a direct impact on ensuring patient safety, audit readiness and execution and enable commercial delivery of the company's product.
Key Responsibilities:
* Develop, implement, and maintain design quality assurance processes in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards.
* Collaborate with R&D teams to ensure quality considerations are integrated into all stages of the product development lifecycle.
* Conduct design reviews and risk assessments, including Failure Mode and Effects Analysis (FMEA), to identify and mitigate potential risks.
* Develop and validate test methods, inspection procedures, and quality control processes for new products.
* Manage design verification and validation activities, ensuring compliance with regulatory requirements and industry standards.
* Creating the required documentation to support effective global regulatory submissions, liaising with external bodies to ensure their speedy acceptance.
* Support the creation and maintenance of Design History Files (DHF) and Device Master Records (DMR) in accordance with regulatory requirements.
* Lead root cause analysis and corrective and preventive actions (CAPA) for design-related issues.
* Participate in the development and implementation of quality metrics and key performance indicators (KPIs) to monitor and improve design quality.
* Prepare and present design quality reports to management, highlighting trends, risks, and opportunities for improvement.
* Provide training and support to R&D and manufacturing teams on quality principles, procedures, and regulatory requirements.
* Stay current with industry standards, regulatory updates, and best practices to continuously improve design quality processes.
Qualifications:
* Bachelor's degree in Quality Assurance, Engineering, Life Sciences, or a related field.
* 3+ years of experience in a design quality engineering role, preferably within the medical device industry.
* 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.
* Proficiency in statistical analysis tools and software (e.g., Minitab.).
* Excellent verbal and written communication skills.
* Ability to work independently and collaboratively in a team environment.
* Strong organizational skills and attention to detail.
* Certification in quality engineering (e.g., ASQ Certified Quality Engineer) is a plus.