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Contact Info
Oran McIvor
Life Science

+353 1 507 9270
oran.mcivor@lifescience.ie
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Details

Quality Engineer


Reference:ASKC-866186 Location: Westmeath
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: See description
May be suitable for: EHS Engineer, Quality Engineer

Our client, a medical technological company is seeking a quality engineer to join their operations in Athlone on an 18-month contract. The candidate will act as the primary contract for liaison with Competent Authorities and management of communication with Competent Authorities primarily focusing on field action, complaints and vigilance activity. Our client is an innovating company within the fields of respiratory care, cardiac care, interventional access, vascular access and anaesthesia.

Roles/Responsibilities:
• Execute the Post Market Surveillance process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events
• Presentation and documentation of the Post-Market Surveillance analysis results and any required actions
• Interface with key business partners (e.g. Manufacturing, Clinical, Executive Management, Regulatory Affairs, PMS team and other functions as required.
• Manage and monitor effectively all elements pertaining to Post Market Surveillance function in line with corporate and regulatory requirements.
• Internal primary point of contact for PMS/Competent Authority Liaison for Complaint, Vigilance and Field Action queries
• Oversee and manage timely, accurate responses to authorities
• Presentation and documentation of the Post-Market Surveillance analysis results and any required actions
• Support the provision of Reports/Trend data Support NC and CAPA related activities, leading and driving to successful outcomes
• Support PMS related project activity as required.
• Coordinate systematic collection of internal and external data to support issue investigations and closures.
• Coordinate and facilitate cross-functional issue reviews as required to support PMS activity
• Provide periodic training for company personnel on the company’s post-market surveillance processes and procedures
• Pro-actively drive improvements in the post-market surveillance approach
• Provide support for the risk management process and provision of PMS data to risk management groups.
• Supervise, Coach/Mentor team members, imparting learning and knowledge
• Support other activities in the post-market surveillance system as required.

Skills/Experience:
• Degree or equivalent with 4/6 years experience medical device or pharmaceutical environment or equivalent - Desirable
• Experience in Post-Market Surveillance with experience in Complaint Handling/Vigilance Reporting – Essential.
• Excellent problem solving, root cause analysis, decision-making skills and technical writing skills are required.
• Good working knowledge of the Medical Device Directive QSR’ and ISO quality requirements is preferred.
• Excellent organisational and project management skills, ability to effectively manage multiple projects.
• Attention to detail and accuracy – essential
• Previous supervisory/management experience, desirable.
• The ability to prioritise tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
• Strong analytical reasoning and ability to work well under deadlines and pressure – essential
• Problem-solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
• The ability to prioritise tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
• French language may be essential/desirable depending on business needs.



If you would like further Information you can contact the recruiter directly:



Oran McIvor | Tel: +353 (0) 1 507 9270