Exclusivity: This position is being managed exclusively by Pale Blue Dot® Recruitment on behalf of our client. All applications and enquiries will be managed directly through ourselves. Are you a driven and experienced Quality Engineer looking for your next big opportunity?A leading medical device company based in Bray, Wicklow is currently seeking a skilled and motivated Senior Quality Assurance Engineer to join their team. Are you a quality professional who’s ready to take on increased responsibility, mentor others, and drive excellence in a high-performing, regulated environment. This opportunity offers real career progression, exposure to a wide range of quality systems and activities, and the chance to make a meaningful impact in a company that values continuous improvement, innovation, and teamwork.Responsibilities include but are not limited to:Lead and manage root cause investigations, ensuring timely and effective NCR and CAPA implementation.Assist the QA Manager with the day-to-day QMS management, ensuring compliance with ISO 13485 and all relevant regulatory requirements.Conduct and support internal audits, driving ongoing compliance and quality improvements.Support and oversee validation activities, including process validations, test method validations, and risk assessments.Provide hands-on quality support for manufacturing, ensuring product compliance and process control.Develop, implement, and maintain SOPs and work instructions to drive quality initiatives and support operations.Act as a key contact for customer quality concerns, complaints, and regulatory inquiries, leading investigations where required.Identify and lead continuous improvement projects to enhance efficiency and product quality.Mentor and support junior quality team members, contributing to a culture of learning and professional growth.Assist in supplier quality management, ensuring robust quality agreements and ongoing compliance.Own and manage the PM/Calibration schedule.Assist with the development of other quality personnel as required.A Bachelor’s degree in Engineering, Quality, Life Sciences, or a related discipline5+ years’ experience in a medical device or regulated manufacturing environmentProven experience with root cause analysis, CAPA management, and failure investigationsTraining in ISO 13485 internal auditing (lead auditor certification preferred but not essential)Strong understanding of quality engineering tools and principles such as FMEA, SPC, risk management, and validationExcellent analytical and problem-solving skills, with a data-driven mindsetEffective communication and interpersonal abilities, with a collaborative approachProficiency in Microsoft Office Suite and quality management softwareWhy Apply ?An opportunity to step up to senior-level responsibilitiesA forward-thinking, collaborative environment that encourages creativity, autonomy, and professional growthDirect influence on product quality, process improvements, and team development Join a company making a real difference in patients’ lives through high-quality medical device technology.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-