Job Description

Quality Systems Engineer - South Dublin

Ref No: DT17765

County Dublin, Republic of Ireland

Competitive salary

Quality Systems Engineer - South Dublin.
This position is being offered as a fixed-term contract of 24 months' duration.

Job Purpose:
Reporting to the Quality Systems Manager, duties will include implementing & maintaining the company’s Quality Management System in accordance with applicable standards and regulations

Responsibilities:

• Be a key driver of cGMP practices within Operations and Quality divisions
• Act as a 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 CAPA's and Internal Audit findings. Support their timely resolution and ensure appropriate actions are taken to prevent recurrence
• Support process 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

Interested applicants should have:

• A primary degree in a Science/Engineering discipline
• A minimum of 5 years' work experience in a Medical Devices \ Pharmaceutical regulated environment working within an established Quality System
• Proven experience leading CAPA's 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