Description
The Certification and Inspection Officer will Be responsible for all aspects of the Quality management system including Audits and would need to have a QMS lead auditing course.Job Title: Certification and Inspection Officer
Location: Galway
Salary: €55,000 - €60,000
Responsibilities
- Conduct Registration, Surveillance and Recertification activities at client facilities to assess their conformity to the related management system standard.
- Conduct the above audits and prepare the associated pre and post audit documentation in accordance with all company procedures.
- Conduct Internal Audits of independent areas of Quality Management System.
- Perform technical reviews of product Technical Documentation to determine compliance with applicable standards and regulations, and to ensure safety and performance.
- Communicate with assigned clients and staff to ensure efficient audit planning and timely resolution of questions and non-conformity's.
- 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
- Perform any other duties as may be required by the Risk Management Officer.
Key Requirements
- Degree or equivalent in Science or Engineering discipline, with a minimum of five years' experience working in the medical device industry.
- Training or qualification as QMS Auditor or QMS Lead Auditor under ISO 13485, with preference given to Notified Body experience and/or CMDCAS certification.
- Strong understanding of international regulatory requirements for medical devices, with particular emphasis on European and Canadian regulation.
- Understanding and working knowledge of International Standards for medical devices, such as ISO, EN, IEC, ASTM, ANSI and/or AAMI.
- Ability to analyze data and write clear, concise summary reports
- Good interpersonal skills, with the ability to relate to people at all levels
- Ability to work on own initiative and to work as a team member
- Knowledge of the related Quality Management System documentation and requirements.
Please see www.realstaffing.com for all exciting jobs in the pharmaceutical/medical device industry. Point of contact for this role: Aaron O'Byrne /