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Quality Engineer

Job description

Job Purpose

Join the Quality team and work to ensure that the company's Quality Assurance responsibilities are fulfilled.

Key Responsibilities:

  • Lead risk management process in compliance with EN ISO 14971 and preparation of risk management files and FMEAs.
  • Compilation and execution of Process Validation Protocols in line with manufacturing.
  • Support Supplier Qualification, Assessment and Audit process at key Suppliers.
  • Establish and maintain incoming, in-process & final inspections requirements and support design and validation test requirements as required.
  • Generates NCRs and CAPAs for defects and ncr's and follow up to ensure effective closure.
  • Responsible for sterilization evaluation documentation and product release.
  • Support calibration and maintenance programs.
  • Manage validation and monitoring in relation to particulate and biocontamination control.
  • Work directly with all departments (including Production, Design & Regulatory) on product development, transfer and improvement projects.
  • Supports the design verification process.
  • Support QMS activities including internal audits.

 

Essential Skills, Qualifications & Experience:

  • Degree in Biomedical engineering/science discipline or Quality Management together with experience in an engineering function, preferably within a medical device or related industry.
  • 2+ years’ experience as a Quality Engineer or within a similar role within medical devices.
  • Strong technical and analytical problem-solving abilites.
  • Knowledge of Medical Device Quality Management System Requirements ISO 13485, MDD 93/42 EEC, 21 CFR Part 820, CMDR.
  • Ability to work independently and as part of a team within a fast-paced environment.

Desirable Skills & Experience:

  • Experience or training in; Validation, Biocompatibility, Ethylene Oxide sterilization or microbiology.
  • Medical Device Design or Quality Assurance experience.
  • Familiarity with Gamp 5 or computer systems validation.

 

To apply for this position please contact Keeva O’Shea at Sigmar Recruitment Tel: +353 91 749264 Email:   koshea@sigmar.ie

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