Skip to content

Quality Engineer II

  • On-site
    • Wicklow, Leinster, Ireland
  • Quality Assurance

Job description

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!

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-

or

Apply with Linkedin unavailable
Apply with Indeed unavailable
Pale Blue Dot® Recruitment logoHomepage
Privacy policy