Overview My client is a medical device organization based in Wicklow with a global presence.
They are seeking an experienced engineer to join their team who has strong experience across New Product Introduction (NPI) and writing/generating technical documentation for new products.
This role will be a design quality engineer, but they are open to reviewing candidates who match this criteria and are currently in different roles.
Non Negotiables 6+ years experience in a similar role (Design, Quality, NPI, R&D Engineer).
Experience writing and generating technical documentation.
Experience working on NPI projects (ideally for Class II Medical Devices or above).
Key Responsibilities Developing and implementing compliance strategies to support New Product Introductions and current marketed products within the areas of design, design transfer, manufacturing, and service.
Ensuring compliance to the QMS and regulatory requirements (e.g.
21 CFR 820, ISO 13485, MDR) while driving process effectiveness and efficiency.
Ensuring plans, protocols, results, and conclusions are generated, reviewed, and approved according to applicable procedures.
Lead the integration, optimization, and ongoing development of the company's design and development processes into their eQMS.
Performing internal audits, for example assessing compliance of the Design History File (DHF) and other program files, to ensure Quality standards and regulatory requirements are addressed.
Participate in external audits as the subject matter expert for design control and associated processes.
Provide Design Quality Engineering oversight and lead relevant design CAPA projects and nonconformance evaluations.
Maintaining product and site certifications through successful external audits.
Driving audit-readiness activities and representing the company to external agencies during audits.
Providing design control guidance and coaching to the wider Quality and R&D teams, partnering with them to ensure a seamless process from design through to registration.
Creating the required documentation to support effective global regulatory submissions, liaising with external bodies to ensure their speedy acceptance.
Leading activities to improve upon the design process within the company, seeking out best practices and implementing this into the QMS.
Provide global regulatory norm compliance guidance and mentorship to both internal and external partner teams and 3rd party test labs.
Prepare detailed documentation for regulatory submissions and potentially intellectual property filings and stay updated with the latest advancements in CGM technology to drive innovation.
About you Bachelor's degree in a relevant scientific/engineering discipline or the ability to show technical understanding of scientific/engineering principles through industrial experience.
Ideally 8-10 years substantial expertise in Design Quality Engineering in the Medical Device industry but can subsidize for 6+ years of relevant experience.
Experience working with regulatory and notified bodies during submissions and external audits.
Excellent knowledge of design control and risk management processes.
Understanding of regulatory requirements, e.g.
ISO 13485/ FDA regulations.
Expertise in design verification and validation methodologies.
Strong knowledge of quality management systems (QMS).
Proficiency in conducting design reviews.
Familiarity with industry-specific design standards and best practices.
For further information click apply now or send your CV to Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance, Design, and Science
Industries Medical Equipment Manufacturing, Staffing and Recruiting, and Pharmaceutical Manufacturing
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