Our client is a Medical Device manufacturer that has been established for over 60 years. They now employ over 2500 team members and their products are available in over 80 countries and they’re still growing, especially in Europe. They are now looking to establish a new division that will enable them to sell their products directly to the UK & Ireland market, as opposed to using 3rd party suppliers.
Due to their commitment to Europe, they are now looking for a Quality Assurance /Regulatory Affairs Manager to ensure all Regulatory and Quality legislations are met at their new site near Dublin Airport. Some of your duties and responsibilities will include: -
* Responsible for RA activities including product registration, compliance audits preparation and responding.
* Manage and maintain compliance of the company to applicable ISO standard and FDA regulation.
* Accountable for complaints, recall issues, non-conformances and quality issues.
* Facilitate self-inspection and quality patrol on production areas
* Lead the investigation of the root cause and formulation of corrections, corrective action and preventive action.
* Review quality inspection reports and evaluates data to recommend shipment judgment or stoppage of production line if necessary.
* Ensure implementation of CAPA, complete documentation and on time closure.
* Plan and implement methods and techniques for continual improvement of products and processes in order to reduce cost.
* Oversee the compliance of document and data control systems.
* Control quality documents and records, procedures and other GMP-related policies by generating revision or creation as necessary.
* Manage the execution of internal and external audits and ensure timely closure.
* Implement an effective operator training and certification program. Also, manage the conduct of QMS trainings.
* Attend to quality audit of suppliers to verify compliance with set specifications and standards.
* Lead improvement activity and Total Quality Control activities of the organization to success.
* Plan and manage the annual budget
* Report the overall status of Quality Management System in the meeting with Management or in other venues.
* Comply with the regulations such as Walmart, EMC, RoHS, WEEE, REACH
* Provide the directions to shop floor and other QMS activities of the organization.
* Performs other related tasks that maybe assigned by the immediate superior.
The Ideal Candidate
It is likely the successful candidate will have the following:
* Ideally a bachelor’s degree in science, engineering or related field, or proven experience in a similar role.
* 3+ years management experience required.
* Experience in in a manufacturing, particularly in the medical device sector.
* Strong knowledge of ISO 13485, FDA regulations and other local and international regulatory requirements.
* Excellent decision making skills, strong leadership and communication proficiency
How to apply
If the above sounds like your ideal role and you have the skills and attributes as listed above, please don’t hesitate to apply today. Please email a copy of your CV in a word document format ASAP!
Key words: #medicaldevice #qualityassurance #regulatoryaffairs #qualitycontrol #management #dublin #ireland
Corrective And Preventive Action (Capa)
Quality Management Systems
Good Manufacturing Practices
Corrective And Preventive Actions
Restriction Of Hazardous Substances Directive