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Contact Info
James Cassidy
Life Science

+353 1 5079250
james.cassidy@lifescience.ie
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Details

Senior Quality Engineer


Reference:JCAIWF-028235 Location: Westmeath
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Senior Quality Engineer

Our client a medical device multinational currently seeks a Senior Quality Engineer to join their team. Reporting to QUality Director the successful candidate will act as the primary contact for liaison with Competent Authorities and management of communication with Competent Authorities primarily focusing on complaints and vigilance activity.

Role/Responsibilities
Key responsibilities will include (but are not limited to) the following:

Established internal primary point of contact for post market surveillance/Competent Authority Liaison for Complaint and Vigilance (and other as required) Queries (Management of Timely responses)
Coordinate systematic collection of internal and external data on product safety and performance to support Complaint File investigations and closures.
Coordinate and facilitate cross-functional product/complaint file reviews as required to support complaint activity
Ensure effective CAPA is taken to help prevent reoccurrence
Final Reviewer/Approval for closure of all Complaint files/Management of file closures to meet Metric Requirements
Provide periodic training for company personnel on the company’s post market surveillance processes and procedures (complaints/vigilance)
Collaborate closely with other sites to share best practices and pro-actively drive improvements in the post market surveillance approach
Support the provision of trend data as required
Provide support for the risk management process and provision of complaint data to risk management groups.
Support other activities in the post-market surveillance system as it develops.
Assist in developing and implementing global policies and procedures
Perform all other work related duties

Skills/Experience

Degree or equivalent with 6/7 years experience medical device environment.
Experiencein Post-Market Surveillancewith experience in Complaint Handling/Vigilance Reporting– essential.
Excellent technical writing experience within a medical device environment – essential
Good working knowledge of the Medical Device Directive and familiarity with its transposition into national legislations within Europe as it affects complaint management.
Good working knowledge of the Quality System Regulations as they pertain to customer complaints.
Excellent organizational and project management skills, ability to effectively manage multiple projects. Attention to detail and accuracy – essential
Previous supervisory/management experience, desirable.
The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
Experience with bio-hazard management/contamination control preferred
Ability to work well under deadlines and pressure
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, Outlookand Excel)
Self driven and ability to work independently and/or as a team player.
Approachable and enthusiastic .Flexible and adaptable.
Good organizational skills with cultural awareness and sensitivity
Good judgment and problem solving ability & is capable of understanding the impact of decision making on both Teleflex Medical and their customers.
Strong collaboration and influencing skills – both internally and externally
Excellent communication skills – both verbal and written
Goal orientated for customer and business objectives
Coaching/Mentoring skills



James Cassidy | Tel: +353 (0) 1 5079250