Quality Systems Engineer - Dublin

Quality Systems Engineer                     Co. Dublin

Are you interested in a new role as a Quality Systems Engineer? INFORM3 are currently on the lookout for an enthusiastic individual wishing to progress in their career with a highly recognised specialist company in their respective industry in a role which provides outstanding training to develop your skills.

This role is suited to someone who has a minimum of 4 years’ experience in within Quality Systems with proven knowledge and expertise in CAPA’s and Internal and External Auditing.

The role will provide you with the ability to learn on the job and work within a great team that strive for improvement.

If you feel you have the requirements and skills for this role, then get in touch to find out more!

Roles & Responsibilities Include:

• You will report to the Quality Systems Manager and you will be implementing & maintaining the Company’s Quality Management Systems in accordance with applicable standards and regulations.
• 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 CAPAs and Internal Audit findings. Support their timely resolution and ensure appropriate actions are taken to prevent recurrence.
• Provide a quality review on a range of documentation including procedures, specifications, investigations, GMP records and other Quality Management System documentation as required.

Skills & Experience Required:

• Degree or equivalent .in a Science/Engineering discipline
• 4+ years’ 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.
• 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.

For any more information on the role please contact Caolán on 015 314 886.

INFORM3 Recruitment is an equal opportunities employer. By applying to this position, you accept the terms of our privacy policy, please find this on our website.