Job ID: JOB-11456
Senior Quality Engineer

A leading medical device company in Galway is looking to hire a Senior Quality Engineer to join their team on a permanent basis.

Description

The Senior Quality Engineer provides a support role to the IDEM Business Unit including Manufacturing Sites. The Senior Quality Engineer reports to the Quality Operations Director/Manager, IDEM.

Responsibilities and Duties

• Possesses and applies comprehensive knowledge of Quality, and its application to the completion of complex assignments.
• Advanced knowledge of the organization’s operations and practices to enable informed decisions, and providing direction to Quality team and other functional areas.
• Responsibility for delivery of projects originated in QA or participate within Core Team for Quality deliverables of business wide projects.
• Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems with effective solutions.
• Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results. Applies risk assessment techniques in such circumstances.
• Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions.
• Drives business improvements through mentoring and support for the continuous improvement initiatives.
• Escalation point for quality related non-conformances and CAPAs.
• Drives compliance cross functionally in alignment with the objective for collaboration and multi-site standardisation and compliance.
• Drives compliance across Business Unit through communication and collaboration to ensure that Quality System requirements are met throughout the organization.

Education & Experience

• Third level qualification.
• Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions, including;
• competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP), awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
• Broad knowledge of engineering and technical applications applied in development of medical devices useful.

Requirements

• Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
• Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
• Proficient with MS Word, Excel, Power Point, and management of spreadsheets.

For further information on this role please contact Clara Burke on 086 816 8273 or science@hero.ie



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Clara Burke

JOB-11456