Design Assurance Lead Our client is seeking a Design Assurance Lead 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 Quality team you will ensure adherence to the Quality Management System (QMS) and regulatory requirements. In this role, you will have a direct impact on ensuring readiness and execution.
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.
Own new product introductions (NPI's) from beginning to end across a variety of marketS.
Collaborate with R&D teams to ensure quality considerations are integrated.
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.
Own and review DHF, DMR, and related documentation for new product development and sustaining projects.
Prepare and present design quality reports to management.
Provide training and support to R&D and manufacturing teams on quality principles, procedures, and regulatory requirements.
Requirements:
Bachelor’s degree in Quality Assurance, Engineering, Life Sciences, or a related field.
5+ years of experience in a design quality engineering role, preferably within the medical device industry.
Demonstrated hands-on expertise in Design Controls lifecycle with minimum 2–3 NPIs delivered from concept through commercialisation.
In-depth knowledge of QMS standards and regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820.
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 01 525 2457. 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.
