Quality Engineer II

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-