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Certification Auditing

Santry, Dublin

Job Description
Job title: Quality Officer Medical Devices 
Division: Medical Devices 
Department: Medical Devices 
FTE: Full Time 
Reports to: Medical Device Operations Manager 
Grade: SSO
Status: Permanent
Location Dublin or Galway 

Job Overview

The Medical devices department in NSAI is a notified body for the following schemes: 
  • Medical Devices Directive 93/42/EEC,  
  • Active Implantable Medical Devices Directive 90/385/EEC,  
  • In Vitro Diagnostic Medical Devices Directive 98/79/EC,  
  • Commission Regulation 722/2012,  
  • Human Blood/ Plasma, 2000/70/EC,  
  • Medical Devices Regulation 2017/745,  
And is accredited to the following assessment services: 
  • MDSAP Recognised Auditing Organization,  
  • ISO 13485 Certification Body Auditing, 
  • ISO 9001 Certification Body Auditing. 
The medical devices department is recruiting for a Quality Officer who will report to the Medical Devices operations managers in Ireland and the USA. The job will be based in either Dublin or Galway and will be primarily office based. 
The Quality Officer will have overall responsibility for maintaining the Medical device quality management system and will actively liaise with the corporate Quality Officer to ensure policies and procedures are aligned.  
Key Tasks and Responsibilities 
Document control activities  
  • Assist local management in the introduction of new procedures and practices to implement new projects 
  • Ensure that the processes and procedures meet the necessary accreditation body requirements 

Corrective and Preventive action activities  
  • Organise Corrective Action and Prevention meetings and maintain minutes from the meetings  
  • Assist in conjunction with a team in performing root cause analysis of non-conformances as they arise from internal and external audits and quality issues  
  • Maintain and track the Corrective action and preventive action system 
  • Ensure effective implementation of CAPA activities across the department  
  • Co-ordinate the CAPA meetings and maintain minutes of the meetings and metrics  
 Customer feedback activities  
  • Maintain the customer feedback log  
  • Initiate actions arising from customer feedback 
Audit activities  
  • Supports all audit preparation activities and documentation preparation for internal audits and accreditation or designation audits, and witness audits. 
  • Coordinate activities with Operations Managers to ensure timely completion and closure of internal and external corrective actions and facilitate the investigation of quality systems issues, help in identifying trends and ensure that corrective active measures are implemented to address the issues. 
  • Plan and organise internal audit activities and report on the results to local and executive management.  Ensure audit processes achieve value (measured in improvement to efficiency, effectiveness and lean management). 
Management review activities 
  • Schedule and attend management review  
  • Gather inputs and outputs from relevant stakeholders 
  • Ensure actions arising from Management Review meetings are tracked and actioned in a timely manner. 
Risk register 
  • Maintain and monitor the risk register in conjunction with the team  
  • Provide feedback to NSAI’s Risk Management system and timely up-dates when new risks are identified. 
Metric maintenance  
  • Ensure that all processes have SMART metrics for their success and assist management in selecting pertinent metrics 
  • Establish and, where already in place, maintain processes to independently monitor metrics and report monthly (or when required) on the performance of the management system against its policies, objectives and process metrics. 
  • Hold training sessions as needed on quality management aspects. 
  • Ensure that systems are in place to identify competence criteria (for evaluators and those being evaluated) and that systems used to demonstrate that competence meets criteria are robust, sound and adequately recorded and maintained. 
  • Represent NSAI on external committees where required. 
  • Perform tasks as may be required assigned by the Medical devices operations managers or Director of medical devices. 
Qualifications and Experience 
  • Successful completion of a university or a technical college degree or equivalent qualification in relevant studies (NFQ level 8 or above). 
  • Knowledge and understanding of the effective implementation of quality system requirements s e.g. ISO 9001, ISO 13485, ISO 14971, ISO 17021 
  • Competent management systems lead auditor with a minimum of 5 years lead auditor experience. 
  •  Excellent interpersonal skills commensurate with building relationships at a senior level and ability to operate at appropriate levels in a business environment. 
  • Highly proficient in spoken and written English. 
Technical Competencies 
  • Knowledge of Quality Management system requirements for certification bodies (ISO 17021). 
  • Good practical knowledge of quality techniques including lean, SPC, risk analysis / FMEA, control plans, flow charting, Ishikawa analysis, process approach etc. 
  • Knowledge and understanding of the Medical Device and In Vitro Diagnostic  directives and regulation and the Medical device single audit programme. 
  • Knowledge and experience with CAPA systems, identifying root cause/corrections/corrective actions. 
  • Excellent communication skills with the ability to relate to people at all levels internal and external to NSAI. 
Core Competencies 
  • Ability to work on own initiative and within a team environment. 
  • Ability to work effectively while meeting specific time frames. 
  • Ability to define problems, collect data, establish facts and draw conclusions and propose effective solutions. 
  • Ability to manage improvements to the management systems to increase effectiveness and efficiency. 
  • Strong writing, presentation and interpersonal skills. 
  • Good leadership and co-ordination skills. 

This job specification is intended as a guide to the general range of duties for this post. It is intended to be neither definitive nor restrictive and will be subject to periodic review with the post holder.

Full details of this role can be found in the Candidate Booklet below: