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-
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