Risk Management Specialist | Collins McNicholas

Risk Management Specialist

  • Reference: 43723
  • Job Type: Permanent
  • Location: Offaly, Westmeath
  • Category: Production

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 Integra Manufacturing sites (Toll Sites) in the area of Risk Management
  • 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.

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Donie Shine

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