Cache of job #13698541

Job Title

Quality & Risk Specialist

Employer

Sanderson Recruitment Ireland

Location

Westmeath

Description

NPI Medical Device Validation & Risk Management Specialist. Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: Provide Risk management expertise , guidance and supervision during project phases. Development and maintenance to risk management files to support new and existing products. (Including - Risk Management Plans, MDHA's, AFMEA, DFMEA, PFMEA, Risk Benefits Analyses, Post Market Surveillance plans. Use knowledge of statistics to assist with the development of Risk assessments and FMEA documentation. Work with team on product transfers from product development to manufacturing. Support Engineering, Regulatory and Manufacturing in Risk management activities as required. Support other Manufacturing sites in the area of Risk Managemen t. Assisting with CAPA investigations. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Hons Degree in Engineering, Quality Engineering or a related technical discipline. A minimum of 2 years experience of working within a Medical device or other regulated industry with knowledge of Risk Management ( ISO 14971), MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), FDA and cGMP. Strong analytical skills and problem solving techniques. Familiar with electronic medical devices manufacturing is an advantage. Familiarity with the requirements of validating product and processes. Working knowledge of statistical analysis. Equipment and Process Validation experience desirable. Excellent communication and skills - written, oral and PC. Please apply for the role via this site: or call Nicola Reid in Sanderson on 01 513 3624 or 086 839 6274. This job originally appeared on RecruitIreland.com.

Date Added

2563 days ago

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