Our client, a leading Medical Device company based in Wicklow, is hiring a Quality Engineer II.Responsibilities include but are not limited to the following:Lead and manage root cause investigations, ensuring timely and effective corrective and preventive actions (CAPA).Take ownership of the day-to-day management of the Quality Management System (QMS), ensuring compliance with ISO 13485 and regulatory requirements.Conduct and support internal audits, ensuring continuous improvement and adherence to quality standards.Support and oversee validation activities, including process validation, test method validation, and risk assessments.Provide quality support for manufacturing operations, ensuring product compliance, process control, and efficiency.Develop, implement, and maintain Standard Operating Procedures (SOPs) and work instructions to support quality initiatives.Serve as a primary quality contact for customer quality concerns, complaints, and regulatory inquiries, leading investigation processes as required.Identify and implement continuous improvement initiatives to drive efficiency and enhance product quality.Mentor and guide junior quality team members, supporting their professional development.Assist in supplier quality management, ensuring robust quality agreements and compliance with regulatory standards.Bachelor's degree in Engineering, Quality, Life Sciences, or a related discipline.3+ years of experience in a medical device or regulated manufacturing environment.Strong expertise in root cause analysis, CAPA management, and failure investigations.ISO 13485 lead auditor training (certification preferred but not required).Proven experience in internal auditing and regulatory compliance.Strong knowledge of quality engineering principles, including FMEA, SPC, risk management, and validation processes.Excellent problem-solving abilities and a data-driven approach to decision-making.Strong interpersonal, communication, and leadership skills, with the ability to collaborate across departments.Proficiency in Microsoft Office Suite and quality management software.This is a fantastic opportunity to join a forward-thinking team and thrive in a collaborative, supportive environment that values creativity and teamwork!Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.-Pale Blue Dot® Recruitment - The Resource for the MedTech Workforce-