Quality System Engineer - Dublin, Ireland - Cpl

Description

Quality Systems Engineer

This role supports the Quality Systems Manager and will include implementing & maintaining the Quality Management System in accordance with applicable standards and regulations.

Responsibilities:

• Be a key driver of cGMP practices within Quality and Operations
• Be the primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements.
• Ensure adherence to internal and external regulatory requirements
• Be an active member of the internal audit team and support external audits at the site
• Maintain effective implementation of site processes including Change Management, Internal Audits and CAPA
• Prepare and present data to management on quality system performance
• Drive thorough investigation & root cause analysis of CAPAs and Internal Audit findings. Support their timely resolution and ensure appropriate actions are taken to prevent recurrence
• Support other Quality processes and implement improvement activities
• Provide a quality review on a range of documentation including procedures, specifications, investigations, GMP records and other Quality Management System documentation as required

Educational Requirements:

• A primary degree in a Science/Engineering discipline

Relevant Experience:

• A minimum of 5 years work experience in the Medical Devices Pharmaceutical regulated environment working within an established Quality System
• Proven experience leading CAPAs and Internal Audits
• Strong problem solving ability
• Experienced in technical writing and review with good attention to detail
• Proven ability of working on own initiative and in a cross-functional team environment
• Excellent interpersonal and communication skills
• Ability to prepare and present data effectively
• Qualified Internal Auditor experience