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Employer ICDS Recruitment
Job Title Certification And Inspection Officer

Certification and Inspection Officer (medical device).

This position is being offered initially as a Fixed-Term contract of 2 years' duration.

The role can be based either in Dublin or Galway according to successful candidate's preference and circumstances.

Job Overview:
The primary function is to undertake third party audits and medical device file reviews.

Key Tasks and Responsibilities:
• Conduct Registration, Surveillance and Re-certification activities at client facilities to assess their conformity to the related management system standards.
• With appropriate training you will be required to cover a wide range of medical device facilities, products, and technologies, but will specialise in the Cardiovascular / Vascular area.
• Conduct the above audits and prepare the associated pre- and post-audit documentation in accordance with all organisational procedures;
• Conduct Internal Audits of independent areas of the organisation’s Quality Management System;
• Perform technical reviews of Medical Device product technical documentation, specialising in the Cardiovascular / Vascular area, to determine compliance with applicable standards and regulations, and to ensure safety and performance;
• Communicate with assigned clients and organisational staff to ensure efficient audit planning and timely resolution of questions and non-conformities
• Stay abreast of technology and regulatory trends affecting certification
• To promote the Certification/Inspection service through the dissemination of information by correspondence, lectures and publications, or otherwise as the opportunity arises
• Respond to technical enquiries and responsible for timely communication and support to clients, administrative staff and Medical Device team members
• Maintain strict confidentiality of matters relating to client work at all times
• Undertake travel to evaluate applications for Certification and Registration Schemes operated by the organisation

Qualifications and Experience Sought:
• Degree in Biomechanical Engineering, with a minimum of five years’ experience working in the medical device industry, ideally with Cardiovascular / Vascular experience
• Training or qualification as QMS Auditor or QMS Lead Auditor under ISO 13485 or other medical device industry standard is highly desirable
• Proven experience working to International Standards, directives, and guidelines for medical devices, such as Medical Device Directives MDD 93/42/EEC; IVD 98/79/EC; AIMD 90/385/EEC, TSE Regulation722/2012; Blood Directive 2000/70/EC and ISO 13485:2012.

Technical Competencies:
• Good understanding of international regulatory requirements for medical devices, with particular emphasis on European regulation
• IT skills with a strong knowledge of word processing, spreadsheet, and presentation packages
• Ability to analyse data and write clear, concise summary reports.

Core Competencies:
• Interpersonal and communications skills are essential as part of working with a multi-disciplinary team dealing with national and international clients
• Ability to work on own initiative taking responsibility for important decisions under pressure and also to work well with colleagues as a team member on complex review projects

• Ability to priorities deadlines and manage multiple tasks
• Strong communication skills and the ability to deal with stakeholders at all levels

This job originally appeared on
Location Galway
Date Added 78 days ago
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