Job Description

Quality Systems Engineer - South Dublin

Ref No: AM17765

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