Sr. Quality Engineer
Job ID: JOB-11365
Sr. Quality Engineer
My client is a well know multination company based in Galway who are excited to announce the new role for a Sr. Quality Engineer within their Global Post Market Surveillance group. As the Quality Engineer, you will work in a team which supports and ultimately guides business units in their regulatory obligations to conduct Complaint Handling, Vigilance reporting and Post Market Surveillance activities. As the successful candidate, you will have 8 years of experience with at least 3 years specifically in Post-Market Surveillance.
About the Job:
- Contributes as part of a geographically dispersed team of quality and data analysis professionals that constitute the Divisional Post Market Surveillance team.
- Possesses and applies comprehensive knowledge of Quality, and its application to the field of Complaint Handling, Vigilance Reporting and Post Market Surveillance.
- Support Global Business Units in executing on Complaint Handling, Vigilance Reporting and Post Market Surveillance activities to meet corporate and regulatory timelines
- Obtain a thorough knowledge of the company’s global operations and structures in order to enable informed decisions and to provide direction to Quality and Regulatory teams and other functional areas.
- Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
- Drives compliance cross functionally in alignment with the divisional for collaboration and multi-site adherence to relevant regulatory requirements.
- 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.
- Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions.
- Responsibility for delivery of projects on behalf of the Division and with the support of the Business Units
- Escalation point for quality related non-conformances and CAPAs.
- Third Level Qualification in related field (Science, engineering or nursing preferable)
- 8+ years of experience in the Medical Device industry; To include: 3+ years’ experience with Post-Market Surveillance, both active and passive, including the generation of periodic reports.
- Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)
- Experience working in electronic complaint management systems
Highly Advantageous Experience:
- Experience supporting in-vitro diagnostics products
- Experience managing customer complaints for medical device or in-vitro diagnostics
For further information on this role please contact Clara Burke email@example.com 0868168273
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