Senior Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob FunctionSupply Chain EngineeringJob Sub FunctionQuality EngineeringJob CategoryScientific/TechnologyAll Job Posting Locations:Galway, IrelandJob DescriptionSenior Quality Engineer – Neurovascular (MedTech)At Johnson & Johnson MedTech, we’re redefining the future of healthcare by combining biology and technology to deliver smarter, less invasive, and more personalized treatments. Join us in shaping the next generation of medical innovation.We are currently seeking a Senior Quality Engineer to join our Neurovascular team at Neuravi, where your expertise will directly impact patient outcomes and drive quality excellence across our operations.ResponsibilitiesAs a Senior Quality Engineer, you will lead and support key quality system processes, ensuring compliance with global regulations and internal standards. Your responsibilities will include the following process for Neuravi:CAPAQSMR (Local and Franchise)DRBMetricsDocument Control & Change Control systemRecord Retention ProgramLeads and/or facilitates compliance and improvement activities associated with the Neuravi quality system (e.g. CAPA, audit programs, personnel training).Monitor compliance with Neuravi policies, procedures, and applicable regulatory requirements, identifying, reporting, and implementing process and system improvements.Manage a staff of 2 or 3 members, assuring compliance with all applicable regulations, policies, and procedures.Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to production, project and team environments, including contributing towards the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.Represent Neuravi professionally and positively externally to agencies, vendors and regulators. Preparation and reporting of data on production, environmental monitoring, vendor assessment, non-conformances and supplier corrective actions for use in management review.Qualifications/RequirementsMinimum 5 years of experience in Quality Assurance, Quality Systems, or Regulatory Affairs within the medical device industry.Strong knowledge of FDA 21 CFR Part 820, ISO 13485:2016, EU Medical Device Directive, and Canadian Medical Device Regulations.Experience preparing for FDA and Notified Body inspections.Auditor certification (preferred).Proficiency in MS Office and other relevant IT tools.Ability to manage multiple priorities in a fast-paced environment.Experience with less invasive medical device technologies and/or implants is a plus.Here’s What You Can ExpectApplication review: We’ll carefully review your CV to see how your skills and experience align with the role.Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process!