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.
Responsibilities:
* Investigation of Customer Complaints for Clients 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 Clients
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 Clients 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 the Clients Code of Conduct is considered in all
business matters carried out on Clients&#**Apply on the website**;s
behalf.
Qualifications / Requirements:
* Third level qualification in Science, Engineering, a relevant
technical discipline or relevant experience.
* Experience in auditing within the Medical Device Industry would be
an advantage.
* Proven knowledge and experience (ideally minimum 4 years) of working
with ISO**Apply on the website**, ISO**Apply on the website**, the
Medical Device Directive, EU Medical Device Regulation **Apply on the
website**/**Apply on the website** and the FDA QSR including **Apply
on the website** CFR Part **Apply on the website** and **Apply on the
website** CFR Part **Apply on the website**, ideally gained in the
medical device industry.
* 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 Quality Technician
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.
Responsibilities:
* Investigation of Customer Complaints for Clients 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 Clients
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 Clients 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 the Clients Code of Conduct is considered in all
business matters carried out on Clients&#**Apply on the website**;s
behalf.
Qualifications / Requirements:
* Third level qualification in Science, Engineering, a relevant
technical discipline or relevant experience.
* Experience in auditing within the Medical Device Industry would be
an advantage.
* Proven knowledge and experience (ideally minimum 4 years) of working
with ISO**Apply on the website**, ISO**Apply on the website**, the
Medical Device Directive, EU Medical Device Regulation **Apply on the
website**/**Apply on the website** and the FDA QSR including **Apply
on the website** CFR Part **Apply on the website** and **Apply on the
website** CFR Part **Apply on the website**, ideally gained in the
medical device industry.
* 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
We need : English (Good)
Type: Permanent
Payment:
Category: Others
