Overview Work as part of the Quality Engineering to provide an efficient service to our customers internally and externally in dealing with product complaints issues and other relevant quality assurance projects as they arise.
Reporting to: Team Lead, Quality Engineering Department: Complaints Responsibilities Department: Complaints Investigation of Customer Complaints for Cook Medical Ireland manufactured products.
Ensuring that all Complaints are properly investigated in accordance with appropriate procedures and FDA/ISO requirements.
Liaison with engineering and other in house groups to determine root cause and solve issues.
Processing and trending of Customer Complaints for Cook Medical Ireland manufactured products.
Preparation, trending and analysis of key Quality metrics including weekly and monthly reports as required.
Providing complaint information to feed into the PMS (Post Market Surveillance) System.
Preparation, execution and analysis of related Quality Documentation.
Supporting Corrective and Preventative Action (CAPA) program.
Supporting Non-Conforming (NCR) program.
Support the Cook Medical Internal Audit program.
Involvement and general support to the Quality group including execution of assigned projects.
Flag related issues with Quality Engineering Team Lead in a timely manner.
Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.
As required by the business, this role can take on tasks as outlined in the Post Market Surveillance Specialist job description.
Qualifications Department: Complaints Third level qualification in Science, Engineering, a relevant technical discipline or relevant experience.
knowledge and experience (( ideally minimum 1 years ) ) of working with ISO13485, ISO14971, the Medical Device Directive, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
Good technical background including technical writing skills.
Knowledge of a GMP regulated environment and experience in a similar role would be an advantage.
Previous experience in dealing with Complaints and Quality System Auditing would be desirable.
Proven Problem-Solving Skills.
Excellent Communication and Inter-Personal Skills.
Excellent Organisational Skills with Attention to Detail Critical.
Good Working Knowledge of Microsoft Office.
Good Working Knowledge of Statistics.
High Self Motivation.