Our client, an innovative and well-established Medical Device leader based in Wicklow, is currently seeking a talented Quality Engineer II to join their high-performing team. This is a unique opportunity to make a real impact in a dynamic and regulated manufacturing environment that values continuous improvement, collaboration, and innovation.
The successful candidate will ensure quality standards are met across all aspects of operations, from managing the QMS and internal audits to handling customer complaints and leading CAPAs. You will collaborate cross-functionally, support validation efforts, and help foster a culture of continuous improvement while contributing to supplier quality excellence.
Responsibilities include but are not limited to:
1. Lead and manage root cause investigations, driving timely and effective CAPA processes.
2. Oversee the Quality Management System (QMS), ensuring compliance with ISO 13485 and relevant regulations.
3. Conduct and support internal audits, ensuring continuous improvement and quality alignment.
4. Guide and support validation activities (e.g., process and test method validations, risk assessments).
5. Provide real-time quality support to manufacturing operations—focusing on compliance, process control, and efficiency.
6. Develop and maintain SOPs and work instructions to support ongoing quality initiatives.
7. Serve as a primary contact for customer quality concerns, complaints, and regulatory inquiries.
8. Lead investigations and coordinate appropriate responses.
9. Drive continuous improvement initiatives across quality processes and systems.
10. Mentor junior team members, offering guidance and support for their growth.
11. Support supplier quality management, including quality agreements and compliance checks.
Requirements:
1. A Bachelor’s degree in Engineering, Life Sciences, Quality, or a related discipline.
2. 3+ years of experience in a medical device or regulated manufacturing environment.
3. Strong expertise in root cause analysis, CAPA management, and failure investigations.
4. ISO 13485 lead auditor training preferred.
5. Proven experience with internal audits and regulatory compliance.
6. Solid understanding of FMEA, SPC, risk management, and validation principles.
7. Excellent problem-solving skills with a data-driven mindset.
8. Strong communication and leadership abilities, with a collaborative approach.
9. Proficiency in Microsoft Office and quality management software.
Why You’ll Love It Here:
Join a progressive company where quality and innovation go hand-in-hand. You'll work in a collaborative environment that encourages growth, creativity, and continuous improvement—all while helping shape the future of MedTech.
#J-18808-Ljbffr