Certification And Inspection Officer

ICDS Recruitment

Dublin North

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 RecruitIreland.com.

2438 days ago