Design Quality Engineer
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.
For You:
* Full time permanent role
* Fully onsite
* Located in North Wicklow, with parking
* Competitive salary and benefit package
* Global impact: Contribute to advancing healthcare diagnostics worldwide
* Career growth: Opportunities for professional development and progression
* Innovative environment: Work with cutting-edge diagnostic technologies
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.
Requirements:
* 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.).
* Ability to work independently and collaboratively in a team environment.
* Strong organisational skills and attention to detail.
* Certification in quality engineering (e.g., ASQ Certified Quality Engineer) is a plus.
For more information, please apply through the link provided for the attention of Nikki Moloney or call Osborne Recruitment on
If you are interested in finding out more about the above role and would like to be considered for this or other suitable roles that we may have available for your skill set – please attach your CV via the link provided. Please submit your updated CV in Word Format.
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.
Osborne are proud to be an Equal Opportunity Employer.
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