A global healthcare company based in Galway now has a vacancy for a Senior Quality Engineer to join their business permanently.
The Senior Quality Engineer leads the Divisional Post Market Quality team which supports and guides the Business Units in discharging their regulatory obligations to conduct Post Market Surveillance activities.
- Possesses and applies comprehensive knowledge of Quality, and its application to the field of Post Market Surveillance, to the completion of complex assignments.
- Obtains an advanced knowledge of ARDxs global operations and structures to enable informed decisions and 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.
- 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 an approach to solutions.
- Drives business improvements through mentoring and support for continuous improvement initiatives.
- Escalation point for quality-related non-conformances and CAPAs.
- Drives compliance cross-functionally in alignment with the divisional for collaboration and multi-site adherence to relevant regulatory requirements.
- Excellent interpersonal, written and verbal communication skills, including the 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, PowerPoint, and management of spreadsheets.
Education & Experience
- Third level qualification.
- Minimum 5 years of experience in the medical device industry with a minimum 3 years of progressively responsible positions, including;
- Experience with Postmarket 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 the development of medical devices useful.
- Health Insurance
- Pension Scheme
- Generous annual leave allowance
- Life Assurance
- Base salary in line with market