Senior Quality Professional

5 days ago


Kilkenny, Kilkenny, Ireland Pale Blue Dot Recruitment Full time

About Our Client

Our client is a forward-thinking Medical Device company based in Wicklow, Ireland. They are committed to delivering high-quality products while adhering to regulatory requirements.

Job Description

  • Lead and manage root cause investigations to ensure timely and effective corrective and preventive actions (CAPA).
  • Oversee the day-to-day management of the Quality Management System (QMS) to ensure compliance with ISO 13485 and regulatory requirements.
  • Conduct and support internal audits to ensure 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 to ensure product compliance, process control, and efficiency.
  • Develop and implement Standard Operating Procedures (SOPs) and work instructions to support quality initiatives.
  • Act as a primary quality contact for customer quality concerns, complaints, and regulatory inquiries, leading investigation processes as required.
  • Implement continuous improvement initiatives to drive efficiency and enhance product quality.
  • Mentor and guide junior quality team members to support their professional development.
  • Assist in supplier quality management to ensure robust quality agreements and compliance with regulatory standards.

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.


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