Cache of job #13697384

Job Title

Risk Management Specialist (Medical Devi

Employer

ICDS Recruitment

Location

Offaly

Description

Risk Management Specialist (medical device) - County Offaly. Job Responsibilities: • 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 Management. • Assisting with CAPA investigations. Qualifications and Experience Required: • Honours 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. This job originally appeared on RecruitIreland.com.

Date Added

2564 days ago

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