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Details

Quality Technical Writer (Medical Devices)


Reference:CK/AIPN-334540 Location: Cork
Qualification:DegreeExperience:See description
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Medical Advisor, Technical Writer

Job Title: Quality Technical Writer (Medical Devices)

Location: Cork

About Company: Our client is an international medical devices company seeking a Technical Writer to join its expanding team.

Duration of role: 12 months

Role overview: To provide support in Quality Operations with regard to Technical writing specifically around compliance, CAPA and Non-Conformances

Duties & Responsibilities:

  • Prepare and finalize basic and complex process documents as assigned with minimal supervision but as part of a quality team with a senior quality engineer
  • Provides input into addressing non-conformances through analysis and providing recommendations for solutions including development/implementation of corrective actions
  • Documents must be of high quality in terms of content, as well as organization per regulatory and internal guidance's, clarity, and accuracy, with attention to format and consistency using established templates.
  • Documents must be prepared within established timelines and in accordance with internal processes.
  • Make decisions that impact presentation in documents that will be viewed by external authorities.
  • Work with senior QA on strategies for the best project management approach within process/timeline constraints and appropriate deviations from normal practice to meet unique challenges.

Essential Requirements

  • Third level qualification preferably in a Science, Engineering or Business-related discipline
  • QC Experience or equivalent
  • Ability to understand Engineering Drawings and Specifications
  • Planning & Organising Skills
  • Influencing Skills
  • Excellent PC skills.
  • Excellent Interpersonal skills
  • Excellent Communications Skills

Desired Requirements

  • 3 years or more in a similar capacity in a regulated industry
  • Previous experience with Documentation control systems