Quality Technician- Complaints

Harmonics Recruitment

Limerick

Responsibilities: Investigation of Customer Complaints for the client’s manufactured products. Ensuring that all Complaints are properly investigated in accordance with appropriate procedures and FDA/ISO requirements. Liaison with Manufacturing, Product Development and other in house groups to determine root cause and solve issues. Processing, classification and trending of Customer Complaints for the client’s manufactured products. Ensuring that confirmed complaints or reportable events are escalated to the appropriate personnel in a timely manner and that relevant vigilance and Medical Device Reports are generated where necessary. 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 client’s Medical Internal Audit program. Involvement and general support to the Quality group including execution of assigned projects. Flag related issues with Senior QE in a timely manner. Ensure that the client’s Code of Conduct is considered with in all business matters carried out on the client’s behalf. Qualifications: Minimum Qualification: Diploma in Science or Quality related discipline. Qualified and experienced Lead Auditor, preferably within the Medical Device Industry. Proven knowledge and experience (min 4 years) of working with ISO13485:2003, ISO14971: 2000, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry. This job originally appeared on RecruitIreland.com.

2767 days ago