Senior Quality Professional
5 days ago
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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