Job ID: JOB-11690

Quality Engineer

 My Client, a leading Global Healthcare provider are looking to recruit a Quality Engineer for their site in Galway. This role is commutable from Mayo and Clare. The primary focus of this role is to be a key contributor to the Divisional Post Market Quality team, which supports and guides the Business Units in discharging their regulatory obligations to conduct Post Market Surveillance activities.

Duties and Responsibilities

• Possesses and applies comprehensive knowledge of Quality, and its application to the field of Post Market Surveillance, to the completion of complex assignments.
• Obtains detailed knowledge of ARDxs global operations and structures to enable informed decisions and to providing direction to BU Quality and Regulatory teams and other functional areas.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Responsibility for delivery of projects on behalf of the Division and with the support of the Business Units.
• 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.
• Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results.  Applies risk assessment techniques in such circumstances.
• Performing detailed quality review and approval of all quality documents, such as procedures, WIs, Change Orders and quality records to check for accuracy, completeness and traceability, both for new documents and after updates have been made.
• Drives business improvements through mentoring and support for the continuous improvement initiatives.
• Drives compliance cross functionally in alignment with the divisional for collaboration and multi-site adherence to relevant regulatory requirements.

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.
• Work collaboratively with others and be aware of cultural differences at the global level.
• Ability to role model compliance behaviors in all situations.
• Work with appropriate parties to manage and resolve Quality System issues.
• Working collaboratively to create, embed and sustain compliance focused outcomes across all Global functions.
• Third level qualification.
• Minimum 3 years of experience in medical device industry.
• Experience with Post market Surveillance, both active and passive, including the generation of periodic reports, Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ISO14971/ cGMP).
• Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL/IVDR/MDSAP).
• Broad knowledge of engineering and technical applications applied in development of medical devices useful.

For further information on this role in Galway, please contact Mark Wilson on 0860449473 or email talent@hero.ie

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Mark Wilson

JOB-11690