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Risk Analysis Specialist (Engineering)

Job Title: Risk Analysis Specialist (Engineering)
Contract Type: Permanent
Location: Offaly
Industry:
REF: 122656
Contact Name: John Reid
Contact Email: johnr@rftgroup.ie
Job Published: 12 months ago

Job Description

Risk Analysis Specialist (Engineering)

Due to continued expansion of their operations our client a well-established Multinational Healthcare Manufacturer now require a qualified and experienced Risk Analysis Specialist
The Risk Analysis Specialist will report to the Engineering Manager.

This is a permanent role based in The Midlands with excellent progression opportunities.

Key Responsibilities of Risk Analysis Specialist:
  • 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 client Manufacturing sites (Toll Sites) in the area of Risk Management
  • Assisting with CAPA investigations.
Requirements of the Risk Analysis Specialist:
  • 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
Please send an up to date CV and cover letter to John Reid at The RFT Group / johnr@rftgroup.ie / on 01-2302400 / www.rftgroup.ie

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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.