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Quality Assurance Manager - Ireland

Quality Assurance Manager - Ireland

May 27,2017

This role will be responsible for creating a quality system for the importation of medical devices into the EU. This includes achieving ISO 13485 certification, obtaining CE Marking for our products, and implementing the necessary quality check for the products to be imported. The Quality Assurance Manager will be the interface between the Asian manufacturers and key customers for quality related issues, including factory audits. 


Key Responsibilities 

Responsibilities include, but are not limited to, the following: 

+ Create and maintain the necessary Quality System for importation of medical devices into the EU. 
+ Achieve ISO 13485 certification for the company and obtain CE Marking for our products. 
+ Ensures EU product and packaging specification meet EU and country specific directives 
+ Review all product technical specifications based on EU and country specific category directives 
+ Confirm all claims which can or must be used on package for each market and has responsibility for CE marking compliance 
+ Maintain QA documentation in accordance with cGMP (current Good Manufacturing Procedures) and ISO 13485 standard requirements. 
+ Overall responsibility for operations as outlined above. 
+ Manage the investigation of non-conformances and complaints, as requested by corporate headquarters and key customers; investigate non-conformances and complaints with vendors resulting in a reduction of future occurrences. 
+ Perform product inspections and in factory quality audits on occasion. 
+ Approve all procedures, specification and technical files that are needed for our products. 
+ Review and approve validation protocol and reports, study protocol and reports. 
+ Manage the change control system and initiate and implement change control procedures as required. 
+ Manage a variable workload to meet operational requirements. 
+ Ensure that all Health, Safety and Environmental requirements are fulfilled. 
+ Create & maintain a culture of total quality & continuous improvement throughout the organisation. 
+ Plan and manage the requirements and priorities of major objectives. 
+ Analysis and resolution of moderately complex management or technical problems. 
+ Operational responsibility for Legal reviews. 
+ Ensure a safe and productive workplace where legislative and commercial obligations are consistently met. 
+ Initiates/approves changes to systems, programs, products, policies to ensure consistency with company philosophy and culture. 
+ Approve functional division budget/operating costs. 



+ Bachelor’s Degree in engineering/sciences (biology, chemistry, etc) or equivalent experience. 
+ 10-12 years experience in medical device quality assurance and FDA/EU regulatory. 5+ years managing people. 
Knowledge and Skills 
+ Experience using an electronic Quality Management System (QMS) or QMS software i.e. MasterControl. 
+ Knowledge of European and FDA regulations, coupled with an understanding of relevant directives, standards, policies and guidelines and the ability to implement appropriately is also required. 
+ Strong communication skills with ability to communicate at all levels within the organization. 
+ Ability to work effectively with others to accomplish goals. 
+ Ability to explore options and make appropriate choices to support the business. 
+ Understanding of customs and beliefs of other groups or cultures. 
+ Excellent Organisational, problem solving skills and attention to detail. 
+ Self motivated, results orientated individual. 
+ Leadership/ Management experience. 
+ Ability to manage and direct the quality function team. 
+ Proficient in MS Excel & Word.

For further details, Please contact Click Here

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