Collins McNicholas

Role Summary:

The Quality Engineer assists in the development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses.

 

Role Responsibilities:

  • Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
  • Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA’s & support the generation of DMF’s where appropriate.
  • Individual with an experienced background in sterilisation, automation, equipment/software validation.
  • Individual with an experienced background in manufacturing within controlled environments.
  • Individual shall support the external & internally Quality Management System auditing function (auditor trained).
  • Individual shall have exposure & involvement in supporting the CAPA system.
  • Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
  • Support the implementation of Company Policies and GMP.
  • Support all company safety and quality programs and initiatives.
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes.
  • Ensure compliance with all learnings from all GMP training events.
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

 

Role Requirements:

  • Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
  • 3 to 5 years’ experience in a Quality Engineering role.
  • Fully competent in Quality Management Standards.
  • Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual).
  • Excellent organisation, communication, computer & presentation skills.
  • Excellent initiative, decision making and be able to work in a core team environment.
  • Solution driven with emphasis on performance and results.

For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email aisling.lane@collinsmcnicholas.ie

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