Our client, a medical device company in Galway is currently looking to recruit a Quality Engineer – Post Market Surveillance for their site.
Reports to: Senior Quality Engineer, Global Post Market Surveillance
The Quality Engineer is 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.
Responsibilities and Duties:
- 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.
- 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.
- 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.
The Ideal Candidate:
- Third level qualification.
- Minimum 3 years of experience in medical device industry including;
- 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.
- Previous experience with International order management or Subject matter expert on International Customer Service processes, procedures and exceptions is desirable.
- 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 the Quality Engineer – Post Market Surveillance role in Galway please contact Orla on 086 0449476/ Talent@hero.ie
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