Senior Quality Engineer
4 weeks ago
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.
Job requirements
- 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
Seniority levelMid-Senior level
Employment typeFull-time
Job functionQuality Assurance and Engineering
IndustriesMedical Equipment Manufacturing and Manufacturing
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