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Quality Systems Specialist

Quality & Laboratory
Cork
Siobhán Lane
Temporary
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Job Reference: JO-2007-65317_1596007009

Summary:


Responsibilities


* Submission of initial and final vigilance reports in accordance with MEDDEV 2.12-1 current revision.


* Co-ordinating timely responses to competent authorities and health ministry's regarding product performance.


* Co-ordinating responses to product performance enquiries from surgeons, patients and health care providers.


* Support litigation cases and co-ordinate the provision of performance data to site legal teams


* Partner with other manufacturing sites and design centres to obtain product performance summaries and data.


* Undertake product performance reviews using available data analysis tools to respond to enquiries.


* Escalate product performance concerns through the established processes


* Participate in product risk assessments providing input in order to evaluate patient risk as required


* Representing the site, be pro-active in shaping and influencing regulatory environment working with Healthcare Industry body groups and Forums (ABHI, Eucomed etc).


* Attend meetings with health care regulators as required.


* Perform all other work-related duties


* Continuous Improvement Focus


* Additional activities as deemed appropriate by the Complaints Manager.



Requirements


* A minimum of a Bachelor's Degree is required.


* Regulatory/Quality Systems experience


* 3+ years Medical Devices Industries experience


* Broad experience and knowledge of world-wide quality system regulations (e.g. FDA 803, 820; ISO 13485, ISO 14971) with a working knowledge of international Health Authority reporting requirements


* Demonstrated proficiency conducting investigations and implementing corrective and preventive actions


* Ability to work in a cross-functional and matrix environment.


* Actively participates in cross-functional team meetings.


* Requires organizational and critical thinking skills.


* Ability to prioritize and multi task.


* Demonstrates ability to respond to the urgent needs of the team, with proven track record of meeting deadline.




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Talent Consultant:
Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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